Deprexil in Subjects With Signs and Symptoms of Depression

Phase 3

Completed

• Conditions: Depression
• Interventions: Dietary Supplement: Deprexil; Dietary Supplement: Placebo

• Registration Number: NCT01043367
• Lead Sponsor: Catalysis SL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-06
• Last Update Posted: 2011-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Deprexil	Deprexil
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

"Heroes del Moncada" Polyclinic; 🇨🇺 Havana City, Havana, Cuba