Deprexil in Subjects With Signs and Symptoms of Depression
Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 depression
Started Jan 2010
Shorter than P25 for phase_3 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 8, 2011
March 1, 2011
1 year
January 5, 2010
March 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
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
Study Arms (2)
A
EXPERIMENTALDeprexil
B
PLACEBO COMPARATORPlacebo
Interventions
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.
Eligibility Criteria
You may qualify if:
- Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration.
- Signed informed consent
You may not qualify if:
- Severe symptoms and signs of depression or Suicide proneness.
- Pregnancy or breastfeeding
- Receiving other experimental drug
- Use of anti-depressive medication within 15 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catalysis SLlead
Study Sites (1)
"Heroes del Moncada" Polyclinic
Havana, La Habana, 10400, Cuba
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria de la Concepción Valdivia Alarcón, MD
"Heroes del Moncada" Polyclinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 6, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
March 8, 2011
Record last verified: 2011-03