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Completed

NCT Number: NCT01109030

Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Tehran, Tehran Province, 14479, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pioglitazone+Citalopram+Chlordiazepoxide

Drug

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+ Chlordiazepoxide

Drug

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 outcomes

  1. 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)

Secondary outcomes

  1. Number of Adverse events in each group

    Time frame: week 2,4,6

  2. Scores of Hamilton Depression Rating Scale (17 items)

    Time frame: week 0,2,4

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 22, 2010
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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