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Sponsors and Collaborators: |
Hadassah Medical Organization Stanley Medical Research Institute |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00158990 |
The purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.
Condition | Intervention | Phase |
---|---|---|
Major Depression Bipolar Disorder Unipolar Depression |
Drug: triiodothyronine Drug: sertraline |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study. |
Estimated Enrollment: | 220 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | July 2007 |
AIM: To determine the therapeutic efficacy and adverse effects of triiodothyronine (T3) as a supplement to the treatment of bipolar depression (BPD) with a mood stabilizer (MS) (lithium - Li, valproic acid - VPA or carbamazepine - CBZ) and the specific serotonin reuptake inhibitor (SSRI), sertraline; and as a supplement to the treatment of unipolar depression (UPD) with sertraline.
METHOD: A random assignment, double blind, placebo-controlled trial separately evaluating patients with a) BPD who are treated with MS + sertraline + T3 or MS + sertraline + placebo and b) UPD who are treated with sertraline + T3 or sertraline + placebo, for up to 8 weeks in both cases. The design of the trial will permit both the outcome of treatment and the speed of response to be evaluated.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Global Medical Institutes | |
Princeton, New Jersey, United States, 08540 | |
Israel | |
Hadassah Medical Organisation | |
Jerusalem, Israel, 91120 |
Principal Investigator: | Bernard Lerer, MD | Hadassah - Medical Organisation |
Study ID Numbers: | BPL-0100-HMO-CTIL |
Study First Received: | September 8, 2005 |
Last Updated: | January 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00158990 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
major depression bipolar disorder unipolar depression sertraline triiodothyronine |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder Mood Disorders Sertraline |
Psychotic Disorders Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |