Deprexil in Subjects With Signs and Symptoms of Depression

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: Deprexil
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration. Signed informed consent Exclusion Criteria: Severe symptoms and signs of depression or Suicide proneness. Pregnancy or breastfeeding Receiving other experimental drug Use of anti-depressive medication within 15 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Deprexil | Dietary Supplement: Deprexil<br>* 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.<br>|
| Placebo Comparator: B<br>Placebo | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 24 weeks | 
| Clinical symptoms of baseline disease at 24 weeks (end of the treatment) |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Dietary supplement, Deprexil