Clinical trial NCT00158990: Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
Official title: Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depression
Bipolar Disorder
Unipolar Depression
Keywords: major depression
bipolar disorder
unipolar depression
sertraline
triiodothyronine
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2005-09-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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).

Primary outcomes:
measure: Response - HAM-D-21 improvement >50% at 8 weeks
measure: Remission - final HAM-D-21 total <7 at 8 weeks
Secondary outcomes:
measure: Rate of change in HAM-D-21 scores over 8 week treatment period
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Global Medical Institutes
state: New Jersey
city: Jerusalem
country: Israel
facility: Hadassah Medical Organisation
Study officials:
affiliation: Hadassah Medical Organization
name: Bernard Lerer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.