Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-10-31

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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pioglitazone+Citalopram+Chlordiazepoxide

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

Group Type ACTIVE_COMPARATOR

Pioglitazone+Citalopram+Chlordiazepoxide

Intervention Type DRUG

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

Placebo+ Citalopram+ Chlordiazepoxide

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.

Group Type PLACEBO_COMPARATOR

Placebo+ Citalopram+ Chlordiazepoxide

Intervention Type DRUG

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

Interventions

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Pioglitazone+Citalopram+Chlordiazepoxide

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

Intervention Type DRUG

Placebo+ Citalopram+ Chlordiazepoxide

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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No