Deprexil in Subjects With Signs and Symptoms of Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043367
• Other study ID #: CAT-0908-CU
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2010
• Last updated: March 6, 2011
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Signs and Symptoms

Intervention

Dietary Supplement:
• Deprexil
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.
• Placebo
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.

Locations

Country	Name	City	State
Cuba	"Heroes del Moncada" Polyclinic	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capabilities at week 24 (end of the treatment)		24 weeks	No
Primary	Social capabilities at week 24 (end of the treatment)		24 weeks	No
Primary	Psycho-affective capabilities at week 24 (end of the treatment)		24 weeks	No
Primary	Behavioral capabilities at week 24 (end of the treatment)		24 weeks	No
Secondary	Tolerability to Deprexil at week 24 (end of the treatment)		24 weeks	Yes
Secondary	Symptoms of depression at week 24 (end of the treatment)		24 weeks	No
Secondary	Signs of depression at week 24 (end of the treatment)		24 weeks	No
Secondary	Clinical symptoms of baseline disease at 24 weeks (end of the treatment)		24 weeks	No