Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression. - Full Text View

Sponsor:	Hadassah Medical Organization
Collaborator:	Stanley Medical Research Institute
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00158990

Purpose

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.

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression Dietary Supplements

Drug Information available for: Liothyronine sodium Sertraline hydrochloride Sertraline Triiodothyronine

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Response - HAM-D-21 improvement >50% at 8 weeks
Remission - final HAM-D-21 total <7 at 8 weeks

Secondary Outcome Measures:

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

Estimated Enrollment:	220
Study Start Date:	October 2002
Estimated Study Completion Date:	July 2007

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158990

Locations

United States, New Jersey
Global Medical Institutes
Princeton, New Jersey, United States, 08540
Israel
Hadassah Medical Organisation
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Stanley Medical Research Institute

Investigators

Principal Investigator:

Bernard Lerer, MD

Hadassah - Medical Organisation

More Information

No publications provided by Hadassah Medical Organization

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Cooper-Kazaz R, Apter JT, Cohen R, Karagichev L, Muhammed-Moussa S, Grupper D, Drori T, Newman ME, Sackeim HA, Glaser B, Lerer B. Combined treatment with sertraline and liothyronine in major depression: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 2007 Jun;64(6):679-88.

Study ID Numbers:	BPL-0100-HMO-CTIL
Study First Received:	September 8, 2005
Last Updated:	January 2, 2007
ClinicalTrials.gov Identifier:	NCT00158990 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

major depression
bipolar disorder
unipolar depression
sertraline
triiodothyronine

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Serotonin Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010