Bipolar Disorder Clinical Trial
Official title:
Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of Major Depressive Episode (MDE) in the context of Bipolar Disorder I or II (BPD-I or BPD-II) or Major Depressive Disorder (UPD), according to DSM-IV criteria, without psychotic features. 2. Hamilton Depression Scale (HAM-D) total >16 with item 1 (depressed mood) >2. 3. Age 18-70 years, male or female. 4. Competent and willing to give written informed consent. Exclusion Criteria: 1. No clinical hyper- or hypothyroidism nor other thyroid illness. 2. No neurological or other physical illness that may impact upon the study or limit prescription of the study medications. 3. No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months. 4. No significant suicidal risk (HAM-D item 3 (suicide) <3). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organisation | Jerusalem | |
United States | Global Medical Institutes | Princeton | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization | Stanley Medical Research Institute |
United States, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response - HAM-D-21 improvement >50% at 8 weeks | |||
Primary | Remission - final HAM-D-21 total <7 at 8 weeks | |||
Secondary | Rate of change in HAM-D-21 scores over 8 week treatment period |
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