A Review on Novel Strategies for Pharmacotherapy of Depression

 

Manan A Patel *, Chetan M Patel, Dipen B Patel, IS Anand and CN Patel

Shri Sarvajanik Pharmacy College, Near Arvind Baug, Mehsana-384 001, India

 

ABSTRACT:

Major depressive disorder is a mental disorder characterized by an all-encompassing low mood accompanied by low self-esteem, and loss of interest or pleasure in normally enjoyable activities. Prevalence rate of major depression is markedly rising all over the world. Pathophysiology of depression is mainly focus on the three major monoamine systems—serotonin (5-hydroxytryptamine, 5HT), nor epinephrine (NE), and dopamine (DA). The emerging new tools of molecular neurobiology and functional brain imaging have provided additional support for the involvement of these three systems. Popular conventional drugs for pharmacotherapy of Depression are Tricyclic anti-depressants, Monoamine oxidase inhibitors and Selective Serotonin Re-uptake inhibitors. Major drawbacks of these drugs include suicide tendency and discontinuation syndrome and there is need of time to focus research at minimising side effects. In last two decades, many new drugs became available in market for pharmacotherapy of depression including novel Selective Serotinin Norepinephrine re-uptake inhibitors and still reserves bright scope in research of anti-depressant. On the other hand, a number of alternative therapeutic strategies are now emerging, as exemplified by the first Substance P receptor antagonist, MK-0869, and several Corticotrophin-releasing factor antagonists now entering clinical trials. Preclinical models predict that some of these new drugs may have a faster onset of action and improved efficacy. It is clear to note that the next generation of drugs will need to tackle some of the unresolved problems of antidepressant therapy such as suicide tendency.

 

KEY WORDS: SSRIs, Drawbacks of antidepressants, advantages of SNRIs, Novel research in antidepressants.

 

INTRODUCTION:

Major depressive disorder is a mental disorder characterized by an all-encompassing low mood accompanied by low self-esteem, and loss of interest or pleasure in normally enjoyable activities.1 In other words, also known as clinical depression, major depression, unipolar depression, or unipolar disorder. The term "major depressive disorder" was selected by the American Psychiatric Association to designate this symptom cluster as a mood disorder in the 1980 version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) classification, and has become widely used since. The general term depression is often used to describe the disorder. Depression is best summarized as virtually a prototype gene-environment interaction model with much focus on the three major monoamine systems—serotonin (5-hydroxytryptamine, 5HT), norepinephrine (NE), and dopamine (DA). The emerging new tools of molecular neurobiology and functional brain imaging have provided additional support for the involvement of these three systems. Now it is evidenced that pre eminent role for central nervous system (CNS) DA circuits exist in pathophysiology of depression.2

 

 


History of Anti-depressants:

Around the mid-1950s; various opiates and amphetamines were commonly used as antidepressants afterwards they fell out of favor due to their addictive nature and side effects. Among herbals, popular was extracts from the herb St John's Wort which have long been used as a "nerve tonic” to alleviate depression. In the following year, they reported that isoniazid improved depression in two thirds of their patients and coined the term antidepressant to describe its action.3 Another anti-tuberculosis drug tried at the same time by Selikoff and Robitzek, iproniazid, showed a greater "psychostimulant" effect, but more pronounced toxicity. Imipramine remained in common use and numerous successors were introduced. The field of MAO inhibitors remained quiet for many years until "reversible" forms affecting only the MAO-A subtype were introduced, avoiding some of the adverse effects.4

 

CLASSES OF ANTI DEPRESSANTS:

1. Tricyclic Antidepressants:

Tricyclic antidepressants are the oldest class of antidepressant drugs. Tricyclics block the reuptake of certain neurotransmitters such as norepinephrine (noradrenaline) and serotonin. They are used less commonly now due to the development of more selective and safer drugs. Side effects include increased heart rate, drowsiness, dry mouth, constipation, urinary retention, blurred vision, dizziness, confusion, and sexual dysfunction. Toxicity occurs at approximately ten times normal dosages; these drugs are often lethal in overdoses, as they may cause a fatal arrhythmia. However, tricyclic antidepressants are still used because of their effectiveness, especially in severe cases of major depression. (Table: 1)

 

Table 1: Past Treatment agents for Pharmacotherapy of Depression

Sr. No.

Class

Drug GenericName

Brand Name

1.

Tricyclic Antidepressants

Amitriptyline

Norpramin

Sinequan

Tofranil

Pamelor

Vivactil

Surmontil

Amoxapine

Desipramine

Doxepin

Imipramine

Nortriptyline

Protriptyline

Trimipramine

 

2.

Atypical Antidepressants

Maprotiline

Trazodone

Nefazodone

Mirtazapine

Bupropion

 

 

 

 

 

 

3.

Monoamine Oxidase Inhibitors (MAOIs)

Selegiline

Isocarboxzaid

Phenelzine

Tranylcypromine

Emsam (Skin Patch)

Marplan

Nardil

Parnate

4.

Selective Serotonin Reuptake Inhibitors (SSRIs)

Citalopram

Escitalopram

Paroxetine

Paroxetine

Celexa

Lexapro

Paxil

Pexeva

 

2. Monoamine Oxidase Inhibitors (MAOIs):

Monoamine oxidase inhibitors are a class of powerful antidepressant drugs prescribed for the treatment of depression. They are particularly effective in treating atypical depression, and have also shown efficacy in smoking cessation.

 

Mode of action: MAOIs act by inhibiting the activity of monoamine oxidase, thus preventing the breakdown of monoamine neurotransmitters and thereby increasing their availability. There are two isoforms of monoamine oxidase, MAO-A and MAO-B. MAO-A preferentially deaminates serotonin, melatonin, epinephrine and norepinephrine. MAO-B preferentially deaminates phenylethylamine and trace amines. Dopamine is equally deaminated by both types.5

 

Reversibility: The early MAOIs inhibited monoamine oxidase irreversibly. When they react with monoamine oxidase, they permanently deactivate it, and the enzyme cannot function until it has been replaced by the body, which can take about two weeks. A few newer MAOIs, notably moclobemide, are reversible, meaning that they are able to detach from the enzyme to facilitate usual catabolism of the substrate. The level of inhibition in this way is governed by the respective concentrations of the substrate and the MAOI.

 

Several drawbacks:

When ingested orally, MAOIs inhibit the catabolism of dietary amines. When foods containing tyramine are consumed (so-called "cheese syndrome"), the individual may suffer from hypertensive crisis. If foods containing tryptophan are consumed, hyperserotonemia may result. The amount required to cause a reaction varies greatly from individual to individual, and depends on the degree of inhibition, which in turn depends on dosage and selectivity.5

 

Withdrawal: Antidepressants including MAOIs have some dependence producing effects, most notably a withdrawal syndrome, which may be severe especially if MAOIs are discontinued abruptly or over-rapidly. However, the dependence producing potential of MAOIs or antidepressants in general is not as significant as benzodiazepines. 5

 

3. Selective Serotonin re-uptake inhibitors :

Mechanism of action: Specific serotonin uptake inhibitors increase 5-HT by inhibiting reuptake. Current theory holds that enhanced stimulation or responsiveness of postsynaptic 5-HT1 receptors   is particularly important in the action of antidepressants.

 

Advantages over Past Treatment: SSRIs had a number of real advantages over the TCAs. It may include:

1.      Easier to prescribe.

2.      Better tolerated.

3.      Much safer in overdose.

4.      Greater efficacy in severe depression

5.      In retrospect, given the high prevalence of untreated depression in the early 1990s and the real limitations of the TCAs (i.e., common side effects and potential lethality in overdose), were reported as reasons of the remarkable commercial success of the SSRIs.

6.         Other medications introduced in the 1980s and 1990s, for example, bupropion, mirtazapine, nefazodone offered selected advantages in comparison to the SSRIs and there was less evidence compared to SNRIs to suggest that any of these medications were more effective for treatment of depressed outpatients.

 

Major Drawbacks:

Suicide tendency: It is believed that selective serotonin reuptake inhibitors (SSRIs) and other antidepressants may increase the risk of suicidal ideation and behaviour in children, adolescents, and adults younger than 25 years.6,7

 

Evidence of Association: Establishing the causal association is difficult because of the clear associations between severe depression and suicide and between severe depression and the need for antidepressant therapy. Because suicide is uncommon, it also is difficult to demonstrate the negative, which is that antidepressants do not cause suicide.  Evidence for and against an association between antidepressant therapy and suicidal thoughts and/or behaviors in children, adolescents, and young adults comes from randomized trials. Thus, individual trials typically lack the power to detect a relationship between antidepressants and suicidal ideation or behavior.

 

Black Box Warning:  In 2004, the United States Food and Drug Administration (FDA) asked manufacturers of a number of antidepressants to make labelling changes to include a warning about a possible increased risk of suicidal ideation or behaviour, particularly at the initiation of therapy or at the time of dose changes. The FDA requires all antidepressants, including fluoxetine, to carry a black box warning stating that antidepressants may increase the risk of suicide in persons younger than 25. After further analysis, in October 2004, the FDA directed manufacturers of all antidepressants (including tricyclic antidepressants and monoamine oxidase inhibitors) to include a warning stating that antidepressants may increase the risk of suicidal ideation and behaviour in children and adolescents.8

 

4.  Natural anti- depressants:

S-Adenosyl-Methionine, or Sam-e for short, is one of the most popular natural antidepressants. In fact, it’s been widely recommended by physicians in Europe for decades and more recently in the U.S. Normally, the brain manufactures this substance from the synthesis of the amino acid methionine. Several herbs like St. John’s Wort are regarded as natural antidepressants. This is due to the presence of hypericin and pseudohypericin, which seem to promote a mild sedative effect. The mechanism behind this activity appears to be related to stimulating 5-HTP reuptake inhibitors at receptor sites, namely L-tryptophan, the precursor of serotonin and melatonin.16 Other natural antidepressants work by inhibiting the activity of monomine oxidase, an enzyme that degrades serotonin, epinephrine and dopamine in the absence of sufficient quantities of essential fatty acids.9

 

5. Selective Serotonin Nor-epinephrine reuptake inhibitors (SNRIs):

Mechanism of Action of SNRIs: SNRIs such as Venlafaxine and duloxetine, referred to as dual-action antidepressants, uniquely block the reuptake of serotonin (5HT), norepinephrine (NE), and dopamine (DA); unique because uptake blockade depends on drug dosage. This mechanism of action contrasts with TCA reuptake inhibition which results in the elevation of 5HT and NE but not DA. Whereas TCAs block 5HT and NE reuptake in a relatively fixed ratio, the SNRIs apparently block 5HT at lower doses, 5HT and NE at medium to high doses, and 5HT, NE, and DA at the highest doses.10

Drawbacks:

1. Suicide tendency: In the last few years, some study results and case reports suggested that taking antidepressants was linked with an increase in suicides, attempted suicides, and thinking about suicide—especially for children, teens, and young adults. Generally, the risk is higher in first month or so and then appears to decrease as the body adjusts to the medication. Depressed individuals may be more likely to attempt or commit suicide whether or not they are taking antidepressants. Nevertheless, in 2004, the FDA required the manufacturers of all antidepressants to include on their labels the following safety warning: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children andadolescents with major depressive disorder (MDD) and other psychiatric disorders.

 

2. Discontinuation syndrome: the abrupt discontinuation of an SNRI usually leads to a discontinuation syndrome which could include states of anxiety and further symptoms. It is therefore recommended to slowly taper down the dose under the supervision of a professional when discontinuing SNRIs. Discontinuation syndrome has been reported to be markedly worse for venlafaxine when compared to other SNRIs.11 This is likely due to venlafaxine's relatively short half-life and therefore rapid clearance upon discontinuation.

 

Advantages of SNRIs:

Superiority: Venlafaxine, the first SNRI, made its debut in 1993 as a multiple dose immediate release (IR) tablet. Despite promising evidence that Effexor offered improved efficacy over SSRIs without the toxicity risk of monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs), patients were not able to tolerate the high incidence of nausea. Wyeth came to the rescue in 1997 by reformulating the drug into an extended release capsule of microspheroids, providing a slower rate of absorption compared with the IR tablet. This new XR formulation showed higher remission rates for major depressive disorder (MDD) when compared to SSRIs and a tolerability profile similar to that of SSRIs.19 Dual-action agents (SNRIs) are more effective than SSRIs in the treatment of MDD. There is a growing amount of evidence to support this hypothesis.12

 

Interest in drugs that inhibited reuptake of both serotonin and norepinephrine was fueled in part by the findings of the Inpatient studies conducted by the Danish University Antidepressant Group (DUAG), in which clomipramine—the only TCA that is a strong inhibitor of serotonin reuptake—was significantly more effective than both citalopram and paroxetine. Several pharmaceutical companies therefore focused on development of selective serotonin norepinephrine reuptake inhibitors (SNRIs), with the aim of introducing antidepressants that conveyed the efficacy advantage of clomipramine while offering a side effect profile more comparable to an SSRI.

 

Drug Profile of SNRIs:

1. Duloxetine:

Trade Name:  Cymbalta 60 mg

It is effective for major depressive disorder and it is as effective as venlafaxine in generalized anxiety disorder, it is a well tolerated and is considered a first line treatment strategy.14 Duloxetine was approved for this indication of stress urinary incontinence in Europe and Canada. A large number of side effects occurring during duloxetine treatment and lack of clear advantage over existing medications prompted critical reviews concluding that duloxetine "should not be used" for stress urinary incontinence.14  Duloxetine was approved by the FDA for depression and diabetic neuropathy in 2004. Mechanism of Action

 

Side effects: Nausea, somnolence, insomnia, and dizziness are the main side effects, reported by about 10% to 20% of patients. 23 In a trial for mild major depressive disorder (MDD), the most commonly reported treatment-emergent adverse events among duloxetine-treated patients were nausea (34.7%), dry mouth (22.7%), headache (20.0%) and dizziness (18.7%), and except for headache, these were reported significantly more often than in the placebo group.

 

2. Venlafaxine:

Brand Name: Effexor, Efexor

In 2007, venlafaxine was the sixth most commonly prescribed antidepressant on the U.S. retail market, with 17.2 million prescriptions.15 Venlafaxine is used primarily for the treatment of major depression, generalized anxiety disorder, social anxiety disorder, OCD, and panic disorder in adults.

 

Investigational uses: Venlafaxine as "off label" used for the treatment of diabetic neuropathy and migraine prophylaxis.16 Due to its action on both the serotoninergic and adrenergic systems, Venlafaxine is also used as a treatment to reduce episodes of cataplexy, a form of muscle weakness, in patients with the sleep disorder narcolepsy. Due to its tendency to increase blood pressure and its modulative effects on the autonomic nervous system, venlafaxine is often used to treat orthostatic intolerance and postural orthostatic tachycardia syndrome.17

 

Mechanism of Action: Venlafaxine is a bicyclic antidepressant, and is usually categorized as a serotonin-norepinephrine reuptake inhibitor (SNRI), but it has been referred to as a serotonin-norepinephrine-dopamine reuptake inhibitor.18 It works by blocking the transporter "reuptake" proteins for key neurotransmitters affecting mood, thereby leaving more active neurotransmitters in the synapse.

 

3. Desvenlafexine:

Desvenlafaxine (Pristiq) is an antidepressant of the serotonin-norepinephrine reuptake inhibitor class from Wyeth. Desvenlafaxine succinate, a serotonin-norepinephrine reuptake inhibitor (SNRI), is the succinate salt of a major active metabolite of venlafaxine hydrochloride known as O-desmethyl venlafaxine.

 

Investigational Uses: Desvenlafaxine is also under investigation for the treatment of vasomotor symptoms associated with menopause. Speroff et al, have reported desvenlafaxine to be an efficient non-hormonal therapy for vasomotor symptoms in postmenopausal women.

 

Mechanism of action: The anti-depressant activity of venlafaxine and desvenlafaxine is attributed to the inhibition of neuronal serotonin and norepinephrine reuptake, and partial inhibition of dopamine reuptake. The inhibition results in the presence of more active neurotransmitters in the synapse region, thereby enhancing the downstream neuronal activity.

 

Side effects: Side-effect profiles were consistent for all three main studies evaluated, Although rates varied substantially from study to study, nausea was consistently the most common complaint (30-50% vs placebo 9-11%) and the most common reason for discontinuation.19,20  Wyeth Pharmaceuticals also reports the following as potential side effects.  headache, sweating, diarrhea, hypertension, abnormal bleeding and/or bruising, glaucoma, increased cholesterol and triglyceride levels, low sodium levels in the blood, and seizures.

 

Adverse effects: The most common adverse effects observed during the treatment included anorexia, constipation, nausea, nervousness, and somnolence.

 

4. Milnacipran:

Brand Name: Ixel, Savella

In January 2009 the U.S. Food and Drug Administration (FDA) approved milnacipran (under the brand name Savella) for the treatment of fibromyalgia, making it the third medication approved for this purpose in the United States. 21

 

Experimental uses: In experimental studies Milnacipran showed useful activity as adjunct in the therapy of fibromyalgia and lupus, both conditions with potentially devastating effects. In fibromyalgia the drug improved pain, mood, and fatigue compared to placebo. In lupus patients pain was alleviated and a sense of well-being was provided.

 

Mechanism of Action: Milnacipran inhibits norepinephrine and serotonin reuptake in a 3:1 ratio, in practical use this means a balanced (equal) action upon both transmitters. The serotonin reuptake inhibition is likely to improve depression, while the norepinephrine reuptake inihibition probably improves chronic pain. Milnacipran exerts no significant actions on postynaptic H1, alpha-1, D1, D2, and muscarinic receptors, as well as on benzodiazepine binding sites.22, 23

 

Side effects: Side effects include itching, nausea, vertigo, increased anxiety, sweating, shivering, dysuria.

 

6. Noradrenergic and specific serotonergic antidepressants (NaSSAs):

Noradrenergic and specific serotonergic antidepressants are a class of psychoactive drugs used primarily as antidepressants. They act by antagonizing various adrenergic and serotonin receptors, of which typically consist of α1-adrenergic and/or α2-adrenergic, and 5-HT2A, 5-HT2C, and/or 5-HT3. Unlike most conventional antidepressants, the NaSSAs have no efficacy as serotonin reuptake inhibitors (SRIs).

 

List of NaSSAs:

1.      Mianserin (Bolvidon, Norval, Tolvon)

2.      Mirtazapine (Remeron)

3.      Setiptiline (Tecipul)

 

1. Mianserin:

Mianserin (Bolvidon, Norval, Tolvon) is a psychoactive drug of the tetracyclic antidepressant (TeCA) chemical class which is classified as a noradrenergic and specific serotonergic antidepressant (NaSSA) and has antidepressant, anxiolytic, hypnotic, antiemetic, orexigenic, and antihistamine effects. It was previously available internationally, however in most markets it has been phased out in favor of its analogue and successor mirtazapine (Remeron).

 

Pharmacology: Mianserin is an antagonist at the H1, 5-HT1D, 5-HT2A, 5-HT2C, 5-HT3, 5-HT6, 5-HT7, α1-adrenergic, and α2-adrenergic receptors, and also acts as a norepinephrine reuptake inhibitor (NRI) via blockade of the norepinephrine transporter (NET).24

 

Side Effects: Common side effects of mianserin may include dizziness, blurred vision, sedation, drowsiness or somnolence, increased appetite or hyperphagia and subsequent weight gain, dry mouth or xerostomia, and constipation, among others. Potentially serious adverse reactions may include and allergic reaction, fainting or syncope, seizures or convulsions, and white blood cell reduction or agranulocytosis.

 

2. Setiptiline:

Setiptiline (Tecipul), also known as teciptiline, is a psychoactive drug of the tetracyclic antidepressant (TeCA) chemical class. It acts as a noradrenergic and specific serotonergic antidepressant (NaSSA), and is thought to have a very similar pharmacological profile to those of mianserin (Bolvidon, Norval, Tolvon) and mirtazapine (Remeron) and acting as an α2-adrenergic, 5-HT2A, 5-HT2C, and 5-HT3 receptor antagonist, among other effects.

 

3. Mirtazapine:

Mirtazapine (Remeron) is tetracyclic antidepressant (TeCA) chemical classes which is used primarily as an antidepressant.

 

Pharmacology: Mirtazapine is a potent antagonist at the following receptors: H1 ,5-HT2A ,5-HT2C ,5-HT3 ,α2-adrenergic. 25 Despite its classification as a NaSSA based on its relatively weak actions at the α2-adrenergic receptor, mirtazapine's antidepressant properties are more likely to actually be mediated primarily by its far stronger blockade of various serotonin receptors, notably the 5-HT2C receptor.

 

Side effects: Common side effects of mirtazapine may include dizziness, blurred vision, sedation, drowsiness or somnolence, malaise or lassitude, increased appetite or hyperphagia.

 

7. Norepinephrine reuptake inhibitors (NRIs):

1. Reboxetine:

Reboxetine is an antidepressant drug used in the treatment of clinical depression, panic disorder and ADD/ADHD, developed by Pfizer. Its mesylate (i.e.methanesulfonate) salt is sold under tradenames including Edronax, Norebox, Prolift, Solvex, Davedax or Vestra.

 

Mode of action: Unlike most antidepressants on the market, reboxetine is a norepinephrine reuptake inhibitor (NRI); it does not inhibit the reuptake of serotonin, therefore it can be safely combined with an SSRI.

 

2. Atomoxetine:

Atomoxetine is a non-stimulant drug approved for the treatment of attentional difficulties. It is sold in the form of the hydrochloride salt of atomoxetine, a Norepinephrine Reuptake Inhibitor.

 

Side effects: The side effects include, dry mouth, insomnia, nausea, decreased appetite, constipation, dizziness, sweating, dysuria, sexual problems, weight changes, palpitations, increases in heart rate and blood pressure.26

 

Off-label uses: Atomoxetine, which inhibits the reuptake of norepinephrine, was originally explored by Eli Lilly as a treatment for depression, but did not show a benefit to risk ratio in trials.

 

3. Viloxazine:

Viloxazine (Vivalan, Emovit, Vivarint, Vicilan) is a bicyclic antidepressant morpholine derivative that acts as a selective norepinephrine reuptake inhibitor (NRI).27

 

Side Effects: Side effects include nausea, vomiting, insomnia, loss of appetite, increased erythrocyte sedimentation, EKG and EEG anomalies, epigastric pain, diarrhea, constipation, vertigo, orthostatic hypotension, edema of the lower extremities, dysarthria, tremor, psychomotor agitation, mental confusion, inappropriate secretion of antidiuretic hormone, increased transaminases, seizure.

 

4. Mazindol:

Mazindol is a central nervous system stimulant. It is a tricyclic compound and mazindol is thought to act as a reuptake inhibitor of norepinephrine. It is marketed under the brand names Mazanor and Sanorex.

 

Indications: Mazindol is used in short-term treatment of exogenous obesity, in combination with a regimen of weight reduction based on caloric restriction, exercise, and behavior modification.

 

8. Selective Serotonin reuptake enhancers (

SSREs):

Tianeptine:

Tianeptine (Stablon, Coaxil, Tatinol), is a selective serotonin reuptake enhancer (SSRE) drug used for treating Major depressive episodes (mild, moderate, or severe). Unlike conventional tricyclic antidepressants, tianeptine enhances the reuptake of serotonin instead of inhibiting it, opposite to the action of SSRIs. Moreover, it enhances the extracellular concentration of dopamine in the nucleus accumbens. 28 Tianeptine, indicated as a thymoleptic, reduces the effects of serotonin in the limbic system and the pre-frontal cortex, giving rise to a mood elevation, unlike the mood blunting associated with SSRIs.

 

Approved Uses:

Tianeptine shows efficacy against serious depressive episodes (major depression), comparable to amitriptyline, imipramine and fluoxetine, but with fewer side effects. It was shown to be more effective than maprotiline in a group of patients with co-existing depression and anxiety.

 

NOVEL DRUGS UNDER RESEARCH AND  DEVELOPMENT:

1. Substance P receptor antagonists:

Until now, the clinical rewards of neuropeptide research have been limited compared with the monoamines. Since the discovery of the first small molecule receptor antagonists of the substance P (SP) preferring neurokinin 1 (NK‑1) 1990, SP has been pursued as a therapeutic target for conditions as diverse as pain, inflammation, emesis and depression. The localisation of SP in brain regions that coordinate stress responses and receive convergent monoaminergic innervation (e.g. the locus coeruleus and the amygdala) suggest that SP receptor antagonists (SPAS) might have potential as  psychotherapeutic agents. Recent behavioural studies using an NK1 receptor knockout mouse have also suggested that SP plays an important role in the adaptive response to stress and emotional behaviour.

 

The clinical development compound MK-0869 (Figure: 1) shows high affinity and selectivity for the NK1 receptor, CNS penetration and good oral bioavailability and is therefore suitable as an oral therapeutic candidate. In a six-week randomised double-blind placebo-controlled trial in outpatients with moderate to severe depression, the effects of the SPA MK 0869 (300 mg) were compared with an active comparator , the SSRI paroxetine (20 mg) or placebo.29 This molecule, provide the first clinically validated new mechanistic non-monoaminergic approach to antidepressant therapy. MK-0869 and other SPAS offer an alternative approach to therapy for depressed patients who respond or comply poorly to currently available drugs. Further clinical trials to confirm and define the therapeutic profile of SPAS are in progress.

 

Figure 1:  Substance P receptor antagonist: MK-0869

 

Where MK-0869 is coding for novel antidepressant molecule

 

2. Corticotrophin-releasing factor antagonists:

There has also been growing interest in the role of another neuropeptide, corticotrophin-releasing factor (CRF), in depression and anxiety disorders.30 There is evidence to suggest that CRF is hypersecreted in depression and stress-related disorders. Post-mortem brain tissue from depressed patients shows a marked increase in the number of hypothalamic paraventricular neurones that express CRF.31 CRF is thought to act both as a neurohormone, stimulating the release of adrenocorticotropic hormone (ACTH) from the pituitary (and subsequently glucocorticoids from the adrenal gland), and a neuromodulator in other brain regions. Two major CRF receptor subtypes (CRFRl and CRFRZ) and a functionally-related peptide, urocortin, have been identified. CRFRl is highly expressed in the brain, including the anterior pituitary, locus coeruleus, neocortex, hippocampus, amygdala and cerebellum, whereas CRFRZ is more abundant in peripheral tissues. Mice with a targeted disruption in the CRFRl locus have been generated to elucidate the specific roles of CRF receptor-mediated pathways. Data indicate that CRF mediates the responses to stress and anxiety via the CRFRl receptor. Animal experiments with acute administration of the nonpeptide CRF antagonist, CP-154,526, ( Figure :2) which has selectivity for the CRFRl subtype produced satisfactory results till date.32  Other antagonists, including DMP696, NB130775 and NGD 98-l are now believed to be entering clinical trials.

 

Figure 2: Corticotrophin-releasing factor antagonists: CP-154,526

 

Where MK-0869 is coding for novel antidepressant molecule

 

3. Modulation of other receptors: Gama amino butyric acid and glutamate:

Gama amino butyric acid (GABA) and glutamate are the principal inhibitory and excitatory neurotransmitters in the central nervous system, respectively. The GABA, receptor is the site at which the anxiolytic and sedative effects of the benzodiazepines are exerted. Other allosteric modulators of the GABA, receptor ion channel have been investigated, including the neurosteroid dehydroepiandrosterone (DHEA) since depressed patients are thought to have abnormally low levels of DHEA.33

 

Two GABA, receptor agonists, NGD 91-2 and NS 2710, are also entering initial clinical trials for anxiety and depression. The presynaptic group II/III metabotropic glutamate (mGlu) agonists, like p-opiate agonists, can suppress the 5- HTinduced glutamatergic excitatory activity in the neocortex. (figure-3) Thus, it is possible that selective glutamate receptor agonists may be beneficial in the treatment of anxiety-related disorders without the adverse effects seen with benzodiazepines. The mechanism of action of antidepressants cannot be unequivocally attributed to their acute pharmacological actions, and their delayed onset may reflect the fact that their therapeutic effect, like the pathogenesis of depression, is an adaptive process. Research has demonstrated that neural plasticity and learning, which may underlie the induction of depression by repetitive stress, involve gene transcription through cAMP Chronic administration of antidepressants up-regulates the cAMP pathway at several levels, including increased expression of the cAMP-response-element-binding protein (CREB). Among the multiple target genes that could be regulated by CREB and that could be involved in antidepressant actions and the pathophysiology of depression is brain-derived neurotrophic factor (BDNF). Immobilisation stress decreased the expression of BDNF in the rat hippocampus.34

 

Figure 3: Gama amino butyric acid and glutamate : DMP-696

 

Where MK-0869 is coding for novel antidepressant molecul Reduced levels of this neurotrophic factor could contribute to the atrophy and decreased function of stress-vulnerable hippocampal neurons. In contrast, chronic antidepressant treatment increased the expression of BDNF in rat hippocampus and could thereby reverse the stress-induced atrophy of neurons or protect these neurons from further damage.. Chronic administration of inhibitors of phosphodiesterase (PDE, the enzyme responsible for the metabolism of CAMP), such as rolipram or papaverine, also increased expression of CREB mRNA in the rat hippocampus. Clinical trials have shown that rolipram has antidepressant efficacy, however the therapeutic potential of this drug may be limited by nausea as a major adverse effect. Up-regulation of the cAMP system thus presents a novel model for the mechanism of action of antidepressants and new targets for the development of therapeutic agents.35

 

DISCUSSION:

A major problem with the current focus on enhancing the efficacy of SSRIs is that this may also enhance the adverse effects. In last two decades, many new drugs became available in market for pharmacotherapy of depression including novel SNRIs and still reserves bright scope in research of anti-depressant.On the other hand, a number of alternative therapeutic strategies are now emerging, as exemplified by the first Substance P receptor antagonist, MK-0869, and several Corticotrophin-releasing factor antagonists now entering clinical trials.Preclinical models predict that some of these new drugs may have a faster onset of action and improved efficacy.It is clear to note that the next generation of drugs will need to tackle some of the unresolved problems of antidepressant therapy such as suicide tendency.

 

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Received on 31.12.2009

Accepted on 20.02.2009     

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Research J. Pharmacology and Pharmacodynamics 2(2): March –April 2010: 153-159