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

Hadassah Medical Center

Status and phase: Completed; Phase 3

Conditions: Major Depression; Bipolar Disorder; Unipolar Depression

Treatments: Drug: triiodothyronine; Drug: sertraline

Study type: Interventional

Funder types: Other

Identifiers

NCT00158990

BPL-0100-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind