Title
Deprexil in Subjects With Signs and Symptoms of Depression
Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.
Phase
Phase 3Lead Sponsor
Catalysis SLStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
DepressionStudy Participants
200The 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.
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.
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.
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