Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder
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Purpose
The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is effective in treatment of moderate to severe depression
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Pioglitazone+Citalopram+Chlordiazepoxide Drug: Placebo+ Citalopram+ Chlordiazepoxide |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder |
- Scores of Hamilton Depression Rating Scale (17 items) at the end [ Time Frame: week 6 ] [ Designated as safety issue: No ]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)
- Number of Adverse events in each group [ Time Frame: week 2,4,6 ] [ Designated as safety issue: Yes ]
- Scores of Hamilton Depression Rating Scale (17 items) [ Time Frame: week 0,2,4 ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | April 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Iran, Islamic Republic of | |
| Department of psychiatry, Roozbeh psychiatric hospital, Tehran University of medical sciences | |
| Tehran, Iran, Islamic Republic of, 14479 | |
| Study Chair: | Shahin Akhondzadeh, PhD | Tehran University of Medical Sciences |
More Information
Publications:
| Responsible Party: | Amirhossein Modabbernia, Dr Amirhossein Modabbernia, Tehran University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01109030 History of Changes |
| Other Study ID Numbers: | 94976 |
| Study First Received: | April 17, 2010 |
| Last Updated: | May 8, 2012 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Tehran University of Medical Sciences:
|
Major depressive disorder pioglitazone double blind placebo controlled |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Citalopram Dexetimide Chlordiazepoxide Pioglitazone Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 22, 2013