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This study looks at whether the effect of the antidepressant sertraline can be strengthened by adding triiodothyronine (T3) and reboxetine in patients with major depressive disorder. Patients aged 18 to 70 with a major depressive episode without psychotic features according to DSM-IV criteria were able to take part. Sponsored by the Hadassah Medical Organization, this study had no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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.