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The investigators hypothesize that Rellidep will be effective in improving the symptoms of major depression. The available evidence strongly suggests that Rellidep contains a mood altering ingredient or ingredients. This open-label, non-randomized study sets out to validate its potential antidepressant activity.The study will include secondary aims of evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom associated symptom of depression and improving quality of life.
About twenty-five patients with major depressive disorder will be assigned to open-label Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various measures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rellidep | Drug | 2000 mg P.O. daily for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Severity and Improvement | 8 weeks | |
| Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks | 8 weeks | |
| Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Sadavoy M.D. | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| C000592697 | rellidep |
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| 8 weeks |
| Beck Depression Inventory Scale (BDI) a t 8 weeks | 8 weeks |
| Hamilton rating scale for Anxiety (HAM-A)at 8 weeks | 8 weeks |
| UKU | 8 weeks |
| D001523 |
| Mental Disorders |