Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

In this project we aim to further refine indications for the use of the thyroid hormone - T3 for patients suffering from depression. We aim to identify a sub-group of patients who are more likely to respond to T3 and establish the time in the treatment course when T3 should be added. The results of this project could have significant, direct clinical implications.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Antidepressive Agents; Reboxetine; Sertraline

Criteria

Inclusion Criteria:

1. Diagnosis of Major Depressive Episode (MDE) in the context MDD according to DSM-IV criteria, without psychotic features.

2. Hamilton Depression Scale (21 items, HAM-D) total >16 with item 1 (depressed mood) >2.

3. Age 18-70 years.

4. Male or female.

5. Competent and willing to give written informed consent.

Exclusion Criteria:

1. Clinical hyper- or hypothyroidism or any other thyroid illness.

2. Neurological or other medical illness that may impact upon the study or limit prescription of the study medications.

3. Significant suicidal risk [HAM-D item 3 (suicide) >2].

4. Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.

5. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.

6. Treatment with the antidepressant, sertraline, in current episode.

7. More then one antidepressant trial or any augmentation treatment during current episode.

8. Length of current episode >12 months

9. Female subjects pregnant or lactating or not using adequate contraception.