Major Depressive Disorder Clinical Trial
Official title:
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | August 2011 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | treatment outcome defined categorically as Remission: A Hamilton Depression Scale (HAM-D) less or equal to 6. | |||
Secondary | RESPONSE: Based on Hamilton Depression Scale (HAM-D)reduction of >50% from baseline to endpoint.. | |||
Secondary | REMISSION: Based on the other rating scales applied in this project. | |||
Secondary | RESPONSE: Based on the other rating scales applied in this project. |
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