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The purpose of the study is to assess the efficacy of DEPREXIL administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of persons to be recruited and randomized for the study is 200.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Deprexil |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deprexil | Dietary Supplement | One 600 mg Deprexil tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional capabilities at week 24 (end of the treatment) | 24 weeks | |
| Social capabilities at week 24 (end of the treatment) | 24 weeks | |
| Psycho-affective capabilities at week 24 (end of the treatment) | 24 weeks | |
| Behavioral capabilities at week 24 (end of the treatment) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability to Deprexil at week 24 (end of the treatment) | 24 weeks | |
| Symptoms of depression at week 24 (end of the treatment) | 24 weeks | |
| Signs of depression at week 24 (end of the treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria de la Concepción Valdivia Alarcón, MD | "Heroes del Moncada" Polyclinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Heroes del Moncada" Polyclinic | Havana | La Habana | 10400 | Cuba |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Placebo | Dietary Supplement | One Placebo tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week. |
|
| 24 weeks |
| Clinical symptoms of baseline disease at 24 weeks (end of the treatment) | 24 weeks |