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

NCT00158990 | Completed Phase 3

• 1 other identifier: BPL-0100-HMO-CTIL
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Major Depression; Bipolar Disorder; Unipolar Depression

Keywords

major depression; bipolar disorder; unipolar depression; sertraline; triiodothyronine

Outcome Measures

Primary Outcomes (2)

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

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

Secondary Outcomes (1)

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

Interventions

triiodothyronine DRUG

sertraline DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Stanley Medical Research Institute: collaborator

Study Sites (2)

Global Medical Institutes

Princeton, New Jersey, 08540, United States

Location

Hadassah Medical Organisation

Jerusalem, 91120, Israel

Location

Related Publications (1)

• 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. doi: 10.1001/archpsyc.64.6.679.

  PMID: 17548749 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Depressive Disorder

Interventions

Triiodothyronine; Sertraline

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Bernard Lerer, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: October 1, 2002
• Study Completion: July 1, 2007
• Last Updated: January 4, 2007

Record last verified: 2005-08

Locations

IL (1); US (1)