Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.

Conditions
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Major Depression, Bipolar Disorder, Unipolar Depression

Intervention / Treatment
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* Drug: triiodothyronine
* Drug: sertraline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Hamilton Depression Scale (HAM-D) total >16 with item 1 (depressed mood) >2. Age 18-70 years, male or female. Competent and willing to give written informed consent. Exclusion Criteria: No clinical hyper- or hypothyroidism nor other thyroid illness. No neurological or other physical illness that may impact upon the study or limit prescription of the study medications. No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months. No significant suicidal risk (HAM-D item 3 (suicide) <3).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: triiodothyronine|nan|
|Drug: sertraline|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response - HAM-D-21 improvement >50% at 8 weeks |  |  | 
| Remission - final HAM-D-21 total <7 at 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in HAM-D-21 scores over 8 week treatment period |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depression, bipolar disorder, unipolar depression, sertraline, triiodothyronine