Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is effective in treatment of moderate to severe depression

Detailed Description
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Pioglitazone as a Ppar-gamma agonist is an anti diabetic drug. It was also shown that, it has certain anti inflammatory and neuro-protective effects. In recent years it has been proposed that Ppar-gamma agonists may have effects on mood and cognition. In animal studies and in one human case report as well as a pilot study on human subjects these drugs improved symptoms of depression. A randomized controlled and double blind design will provide further evidence for the efficacy of these drugs in major depressive disorder.

Official Title
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Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Pioglitazone+Citalopram+Chlordiazepoxide
* Drug: Placebo+ Citalopram+ Chlordiazepoxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Major depressive disorder based on DSM-IV TR criteria Age 18-50 Hamilton Depression Rating scale >=22 Signing the informed consent form Citalopram be the drug of choice for the patient irrespective of other eligibility criteria Exclusion Criteria: Problems in other Axes Pregnancy and lactation Serious or life threatening disease taking other antidepressant in the recent month or Electroconvulsive shock in the recent two months, and taking other psychotropic agents Diabetes controlled with drugs or insulin (patients with only lifestyle interventions will be included), Liver disease, Congestive heart failure Class III and IV Metabolic syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pioglitazone+Citalopram+Chlordiazepoxide<br>Pioglitazone 15 mg Q12h will be given to the patients in active comparator group for 6 weeks. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks.Chlordiazepoxide 10 mg/day for first three weeks | Drug: Pioglitazone+Citalopram+Chlordiazepoxide<br>* Pioglitazone 15 mg every 12 hours for six weeks Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks. Chlordiazepoxide 10 mg each night for first three weeks<br>|
| Placebo Comparator: Placebo+ Citalopram+ Chlordiazepoxide<br>Placebo 1 Q12h for 6 weeks with the same shape and color as Pioglitazone. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks. Chlordiazepoxide 10 mg each night for first three weeks. | Drug: Placebo+ Citalopram+ Chlordiazepoxide<br>* Placebo 1 Q12h for 6 weeks with the same shape and color as Pioglitazone. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks. Chlordiazepoxide 10 mg each night for first three weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of Hamilton Depression Rating Scale (17 items) at the end | Hamilton Depression rating scale is a 17-item scale. The questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. The questionnaire is presently one of the most commonly used scales for rating depression in medical research. The primary outcome measure is Scores on Hamilton Depression Rating Scale at the end (week 6) | week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse events in each group |  | week 2,4,6 | 
| Scores of Hamilton Depression Rating Scale (17 items) |  | week 0,2,4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder, pioglitazone, double blind, placebo controlled