Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

May 8, 2012 updated by: Amirhossein Modabbernia, Tehran University of Medical Sciences
The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is effective in treatment of moderate to severe depression

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 14479
        • Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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
Placebo Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores of Hamilton Depression Rating Scale (17 items) at the end
Time Frame: 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)
week 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Chair: Shahin Akhondzadeh, PhD, Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 17, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94976

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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