Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Pioglitazone+Citalopram+Chlordiazepoxide; Drug: Placebo+ Citalopram+ Chlordiazepoxide

• Registration Number: NCT01109030
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-17
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pioglitazone+Citalopram+Chlordiazepoxide	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
Placebo+ Citalopram+ Chlordiazepoxide	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.

Primary Outcome Measures

Name	Time	Method
Scores of Hamilton Depression Rating Scale (17 items) at the end	week 6	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)

Secondary Outcome Measures

Name	Time	Method
Number of Adverse events in each group	week 2,4,6
Scores of Hamilton Depression Rating Scale (17 items)	week 0,2,4

Trial Locations

Locations (1)

Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences; 🇮🇷 Tehran, Iran, Islamic Republic of