Research on antidepressants in India : Indian Journal of Psychiatry

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Research on antidepressants in India

Avasthi, Ajit; Grover, Sandeep; Aggarwal, Munish

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Indian Journal of Psychiatry 52(Suppl1):p S341-S354, January 2010. | DOI: 10.4103/0019-5545.69263
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Antidepressants as a class of drugs are used primarily in the management of depressive disorders and anxiety disorders. However, this class of drugs is also used for the management of sexual dysfunction, eating disorders, impulse control disorders, enuresis, aggression and some personality disorders.

Over the years many classes of antidepressants have become available in India, some of which have stood the test of time and are still in use and some, which are no more marketed or are no more a favorite of clinicians. The research focusing the usefulness of antidepressants in India has more or less followed the trends in the west; however, some of the antidepressants drugs which have been marketed have not been evaluated as thoroughly as others.

Most of the studies done in India have evaluated various antidepressants in depression. There are very few studies which have evaluated antidepressants in conditions other than depressive disorders. In this article, we review studies done in India on various antidepressants. The review shall focus on the research published in Indian Journal of Psychiatry and studies reported in PubMed indexed journals on efficacy, effectiveness, usefulness and tolerability issues of antidepressants in human subjects.

Efficacy/effectiveness in Depression

The trials done to evaluate the efficacy of antidepressants can be divided into studies evaluating an antidepressant (no comparator studies), efficacy of an antidepressant with placebo as a comparator, comparing efficacy of 2 active drugs and those evaluating the efficacy of antidepressants with other modalities of treatment like electro-convulsive therapy or psychological treatment.

Non Comparative Studies

A total of 18 open trials without a comparator group have been conducted to evaluate the efficacy of various antidepressants [Table 1].[118] Studies done in the 1960s evaluated the efficacy of tricyclic antidepressants. Later studies have evaluated the efficacy of nitroxazepine, centpropazine, amineptine, tianeptine, sertraline and milnacipran. Studies done prior to 1990s have not used any standardized rating scales, most of these also did not mention the diagnostic criteria used for the diagnosis. These studies included subjects diagnosed with various subtypes like reactive depression, endogenous depression, psychoneurotic depression, melancholic depression etc. However, the studies done after 1990s have recruited subjects diagnosed on the basis of DSM or ICD-10 RDC criteria and used standardized rating scales to evaluate the efficacy or effectiveness. The sample sizes of the studies have varied a lot, most of the earlier studies included less than 50 subjects; however, some of the recent studies have included more than 300 subjects. Most of these trials have evaluated the outcome after six weeks. All these trials have shown that various tricyclic antidepressants, nitroxazepine, centpropazine, amineptine, tianeptine, sertraline, escitalopram and milnacipran are efficacious in treatment of depression. The trial which evaluated the efficacy of sertraline also showed that treatment of depression with sertraline leads to reduction in cardiac events post myocardial infarction.[13] A recently published trial, which evaluated the efficacy of milnacipran, included subjects who had suffered from stroke.[18] It is also one of the few trials which have included subjects more than 65 years of age. The trial done by Margoob et al.[17] in addition to the efficacy of escitalopram, have also shown that gene polymorphism plays an important role in the treatment response to various antidepressants.

Table 1:
Non comparative studies evaluating efficacy of antidepressants in depressive disorders

Placebo-Controlled Trials

Six placebo controlled trials have evaluated the efficacy of tricyclic antidepressants in depression [Table 2].[1924] Four of these trials have been double blind controlled trials,[1922] one recruited subjects by consecutive sampling,[23] and one followed cross over design.[24] The duration of these trials has varied from four to eight weeks and these have included 16 to 96 subjects. Of the five trials, one evaluated the efficacy of imipramine in depressive symptoms in schizophrenia[24] and another included subjects with endogenous depression only.[23] Five of these trials showed that amitriptyline, imipramine, protriptyline and trimipramine are better than placebo in the management of depression;[1923] however, the trial which evaluated the efficacy of imipramine for depressive symptoms in schizophrenia showed negative findings.[24]

Table 2:
Placebo controlled trials evaluating the efficacy/effectiveness of antidepressants in depressive disorders

Active Comparator Group Drug Trials of Efficacy

There have been 18 trials which have compared two antidepressants.[2541] One trial compared amitriptyline with amitriptyline and trifluperazine combination[42] and one trial compared amineptine vs. amineptine with benzodiazepine.[43] In another trial nortriptyline was compared with nortriptyline plus fluphenazine [Table 3].[44] The duration of these trials have varied from 10 days to five months; however, most of these have been of four to six weeks duration. Sample size has also varied considerably ranging from 20 to 425 and only four trials have included 100 or more subjects. In terms of study design, 10 trials have followed double blind controlled design; five of these also followed adequate randomization. One trial followed single blind randomized control design and another three trials were open randomized controlled trials. Earlier trials used mixed group of depressive subjects, whereas, recent trials have included subjects with major depressive disorder only. All the trials have used standard doses of antidepressants.

Table 3:
Active comparator group drug trials of efficacy/effectiveness of antidepressants in depressive disorders

Of the 21 trials, 18 have assessed the outcome of depression at the end of trial on Hamilton depression rating scale. Findings from these trials suggest that imipramine is superior to Nialmide,[25] phenelzine,[25] Go 2998,[24] Go 2330[26] and moclobemide[37] in the treatment of depression. Antidepressants like noveril,[27] iprindole,[28] trimipramine,[29] dothiepin[31] and centpropazine[34] have efficacy similar to imipramine. Imipramine has been found to be inferior to sintamil.[30] The study which evaluated amitriptyline and trifluperazine combination showed that it was no better than amitriptyline alone.[42] Interestingly, the study which used fluphenazine found it to be as efficacious as nortriptyline.[44] Nitroxazepine has been shown to be better than doxepin in treatment of depression.[32] The amineptine trial, didn’t present data with regard to comparison in efficacy between the various groups of medications.[43] The studies which have compared various selective serotonin reuptake inhibitors have shown that these are equally effective, except for one which showed that citalopram was better than sertraline.[41] The only trial done on mirtazapine suggests that it is better than amitriptyline.[35] Studies have also shown that citalopram[38] and tianeptine[11] are as efficacious as amitriptyline. The trial by Badyal et al.[39] suggests that duloxetine is as efficacious as venlafaxine in the treatment of major depression. One of the recent multicentric trials have shown that escitalopram is superior to investigational drug LY2216684.[41]

Active Comparator Group (non-pharmacological treatment/electroconvulsive therapy) Trials of Efficacy/Effectiveness.

One study has compared the usefulness of antidepressants with respect to non pharmacological treatment[45] and two studies have compared antidepressants with electroconvulsive therapy for treatment of depression.[4647] Another study compared antidepressants with both electroconvulsive therapy (ECT) and non-pharmacological treatment [Table 4].[48]

Table 4:
Active comparator group non-drug trial of efficacy of antidepressants in treatment of depressive disorders

One of these studies has shown that pharmacotherapy is more effective and more economical than non-pharmacological treatment.[45] However, one study showed no difference between ECT, antidepressant and Sudarshan kriya in the management of depression over the period of three weeks.[48] The studies which compared ECT with imipramine didn’t find any difference in efficacy between the two;[4647] however, Gangadhar et al. reported quicker response with ECT compared to imipramine.

Dosing Studies of Antidepressants [Table 5]

Seven trials have evaluated the different dosing schedules for treatment of depression.[4956] These studies suggest that parenteral imipramine is better than oral imipramine and possibly the onset of action is also earlier.[49] Studies have evaluated single dosing versus multiple dosing have shown no difference in efficacy[50525455] except for one study, which showed that single dose nitroxazepine was better than divided doses.[53]

Table 5:
Dosing studies of antidepressants

Prescription Patterns of Antidepressants in Depression

Chakrabarti and Kulhara[5758] evaluated the antidepressant prescription pattern in a tertiary care hospital for management of depression during acute and continuation phase. For the evaluation of prescription pattern during the acute phase, case notes of 108 cases fulfilling the ICD-10 criteria of depression or recurrent depression (F32 and F33) were examined. Imipramine was the most commonly prescribed antidepressants followed by Fluoxetine. The authors also observed that pharmacotherapy was often deficient in several areas such as, starting doses, rate of increase in dose, maximum doses used, dose titrations, duration of treatment, change of drugs, recording of side-effects and compliance etc. Results regarding norms for adequate doses and periods of treatment before switching drugs, for the kind of subjects included in this study, were unclear. Regarding the continuation phase treatment, the authors observed that it was deficient in about a third (n = 24; 34 %) of the cases, on either of the two parameters i.e., dose of drugs or duration of treatment and the outcome was poorer in those treated inadequately.

Efficacy/effectiveness in Disorders Other Than Depression Obsessive compulsive disorder/symptoms [Table 6]

One double blind controlled trial has evaluated the efficacy of clomipramine in the treatment of OCD and showed that clomipramine was superior to placebo in the management of OCD.[59] This study also showed that male subjects showed better response than female subjects. Another study evaluated the efficacy of clomipramine in late onset OCD with comorbid Parkinsonism and showed that clomipramine can be used in elderly subjects and in the presence of Parkinsonism.[60] A small open label study evaluated the usefulness of neuroleptic and fluoxetine combination for treatment of obsessive compulsive (OC) symptoms occurring during the course of schizophrenia and showed that addition of fluoxetine leads to significant improvement in OC symptoms.[61]

Table 6:
Efficacy/effectiveness/usefulness of antidepressants in other disorders

Insomnia [Table 6]

One study evaluated the efficacy of antidepressants in insomnia and showed that trimipramine was similar to nitrazepam for treatment of insomnia, especially in the presence of anxiety and depression; however, it had poor tolerability as compared to nitrazepam.[62]

Generalized Anxiety Disorder [Table 6]

One trial included subjects with generalized anxiety disorder, mixed anxiety depression and dysthymia and showed that imipramine was as effective as diazepam for anxiety symptoms and better than diazepam for the depressive symptoms.[63]

Depressive Symptoms in Schizophrenia [Table 6]

One trial used imipramine in combination of chlorpromazine and compared it with chlorpromazine alone in the treatment of depressive symptoms in schizophrenia and didn’t find any benefit of adding imipramine to chlorpromazine in the treatment of treatment of depressive symptoms in schizophrenia.[64]

Common Mental Disorders [Table 6]

Two studies have also studied the usefulness of antidepressants in common mental disorders. One study showed that treatment completion rates were higher with fluoxetine than imipramine.[65] The trial by Patel et al.[66] included subjects with common mental disorders and evaluated the outcome at one year. It can be considered the longest study which has evaluated the effectiveness of antidepressant in Indian subjects.

Sexual Dysfunction [Table 6]

Various sexual side-effects of antidepressants have been utilized for the management of sexual dysfunction. In a recently published open trial Dhikav et al.[67] compared fluoxetine with yoga for the management of premature ejaculation. The study included 68 subjects, of whom 38 were in the yoga group and 30 subjects in the fluoxetine group. All 38 subjects (25-65.7% 5 good, 13-34.2% 5 fair) of yoga group and 25 out of 30 of the fluoxetine group (82.3%) had statistically significant improvement in premature ejaculation and the difference between the two groups was statistically significant too. In an open clinical study, Prusty and Rath (2000)[68] found clomipramine effective in nocturnal emission. In another open trial, Prusty et al. (2003)[69] found clomipramine 5 mg along with Sildenafil 50 mg was successful in preventing premature ejaculation of 18 men who had erectile dysfunction also.

Childhood Onset Disorders [Table 7]

Two studies have evaluated imipramine for management of enuresis in children.[7071] In one of these trials,[71] in addition to enuresis, children had other behavioral abnormalities too. These studies have shown that imipramine is useful for management of enuresis and also for behavioral problems like obstinacy and temper tantrums. It was further seen that compared to subjects with mental retardation, the response to imipramine was better in children with average intelligence.

Table 7:
Studies evaluating the efficacy of imipramine in childhood onset disorders

Usefulness in other conditions [Table 8]

Besides the above studies, case series and case reports have also shown usefulness of antidepressants in the management of trichotillomania with trichobezoar,[72] Atypical bulimia Nervosa,[73] Skin Picking,[74] Persistent developmental stuttering,[75] primary hypersomnia,[76] cognitive functioning in depression,[77] proctalgia fugax with dysthymia,[78] palmar-plantar hyperhidrosis,[79] severe resistant depression[80] etc. One open label study also evaluated the usefulness of sertraline in chronic tension type headache and showed that sertraline leads to significant reduction in mean analgesic intake per week, but there is no difference in reduction of headache index and frequency of headache.[81]

Table 8:
Usefulness of antidepressants (findings from case reports/case series/descriptive studies)

Tolerability of Antidepressants

As is evident from Tables 1 to 6, tricyclic antidepressants are poorly tolerated compared to the newer antidepressants. Additionally, there are multiple case reports implicating various antidepressants for induction of hypomania/mania,[8796] hyponatremia/Syndrome of inappropriate antidiuretic hormone secretion (SIADH),[9799] extrapyramidal symptoms,[100] acute colonic (pseudo) obstruction (Ogilvie syndrome),[101102] psychosis,[103] hypertension,[104] vascular headache,[105] torsades de pointes,[106] alopecia,[107] cardiogenic shock,[108] seizures,[109110] galactorrhoea,[111] mania on withdrawal of antidepressants,[112] upper gastrointestinal bleeding,[113] bleeding gums,[114] serotonin syndrome[116117] etc [Table 9].

Table 9:
Side-effects of antidepressants

Antidepressant Withdrawal/Dependence

One case report presented tricyclic withdrawal syndrome with amitriptyline 300 mg/day[121] and another was described by Jhirwal and Chakrabarti[122] with Venlafaxine. Dependence syndrome has been described with dothiepin 450 mg/day.[123]

Safety in Overdose

In a case report, Gupta et al.[115] described a patient who could tolerate paroxetine 560 mg/day.

Conclusion and Future Directions

Many studies have evaluated the efficacy of antidepressants in depression and have shown that most of the currently marketed antidepressants are useful. In addition, studies also suggest usefulness of antidepressants in generalized anxiety disorder, dysthymia and common mental disorders. Many of the recent studies have been of good design and have followed double blind randomized controlled design and had reasonable sample size. Further, several studies have been carried out at multiple sites throughout the country. The available data also suggest that antidepressants are more cost-effective than other modalities of treatment for depression.

In addition, there is some evidence to suggest the usefulness of clomipramine in OCD and that of fluoxetine in management of OC symptoms in schizophrenia. However, some major limitations of the research have been that almost all the data available in relation to treatment of depression pertains to acute phase treatment and rarely studies have evaluated the continuation phase treatment. There is also lack of data with regard to the efficacy and effectiveness in the maintenance phase treatment. Surprisingly, no study has evaluated the efficacy/effectiveness of SSRIs in the management of OCD.

There is a need to conduct studies to evaluate the usefulness of antidepressants in the management of panic disorder and depression in medically ill subjects. Studies are also required to evaluate the efficacy of SSRIs in the management of OCD, and to study the usefulness of polypharmacy in the management of depression and other disorders. Studies are few and sparse and there is a need for multi-centric studies in such a vast country.


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Antidepressants; research; India

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