Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Pioglitazone+Citalopram+Chlordiazepoxide; Drug: Placebo+ Citalopram+ Chlordiazepoxide

Study type: Interventional

Funder types: Other

Identifiers

NCT01109030

94976

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

Pioglitazone+Citalopram+Chlordiazepoxide

Active Comparator group

Description:

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

Treatment:

Drug: Pioglitazone+Citalopram+Chlordiazepoxide

Placebo+ Citalopram+ Chlordiazepoxide

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo+ Citalopram+ Chlordiazepoxide