NCT01109030

Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-04-22
• Last updated: 2012-05-09

Locations

1 site across 1 country: Iran