Major Depression, Bipolar Disorder, Unipolar Depression
Conditions
Keywords
major depression, bipolar disorder, unipolar depression, sertraline, triiodothyronine
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.
Interventions
DRUGsertraline
DRUGtriiodothyronine
Sponsors
Stanley Medical Research Institute
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response - HAM-D-21 improvement >50% at 8 weeks | — |
| Remission - final HAM-D-21 total <7 at 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of change in HAM-D-21 scores over 8 week treatment period | — |
Countries
Israel, United States
Outcome results
None listed