Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

Tehran University of Medical Sciences50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Pioglitazone+Citalopram+ChlordiazepoxideDRUG

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+ ChlordiazepoxideDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Scores of Hamilton Depression Rating Scale (17 items) at the end

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)

Time frame: week 6

Secondary Outcomes

Number of Adverse events in each group

Time frame: week 2,4,6

Scores of Hamilton Depression Rating Scale (17 items)

Time frame: week 0,2,4

Data from ClinicalTrials.gov

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