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

Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depression; Bipolar Disorder; Unipolar Depression

Intervention: triiodothyronine (Drug); sertraline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Bernard Lerer, MD, Principal Investigator, Affiliation: Hadassah - Medical Organisation

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Response - HAM-D-21 improvement >50% at 8 weeks

Remission - final HAM-D-21 total <7 at 8 weeks

Secondary outcome: Rate of change in HAM-D-21 scores over 8 week treatment period

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Hadassah Medical Organisation, Jerusalem 91120, Israel

Global Medical Institutes, Princeton, New Jersey 08540, United States

Additional Information

Starting date: October 2002
Last updated: January 2, 2007

Page last updated: August 23, 2015

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