Loading clinical trials...

Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00158990•Hadassah Medical Organization

View on ClinicalTrials.gov

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.

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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 (2)

Global Medical Institutes

Princeton, New Jersey, United States

Hadassah Medical Organisation

Jerusalem, Israel

Key Dates

Start Date

October 1, 2002

Completion Date

July 1, 2007

Last Updated

January 4, 2007

Enrollment

220

Estimated participants

Conditions

Major DepressionBipolar DisorderUnipolar Depression

Interventions

triiodothyronine

DRUG

sertraline

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

CBT-CP for Veterans With SMI

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder