Deprexil in Subjects With Signs and Symptoms of Depression

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01043367
First received: January 5, 2010
Last updated: March 6, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Depression
Dietary Supplement: Deprexil
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.

Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Functional capabilities at week 24 (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Social capabilities at week 24 (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Psycho-affective capabilities at week 24 (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Behavioral capabilities at week 24 (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability to Deprexil at week 24 (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Symptoms of depression at week 24 (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Signs of depression at week 24 (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical symptoms of baseline disease at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Deprexil
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 Comparator: B
Placebo
Dietary Supplement: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043367

Locations
Cuba
"Heroes del Moncada" Polyclinic
Havana City, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Maria de la Concepción Valdivia Alarcón, MD "Heroes del Moncada" Polyclinic
  More Information

No publications provided

Responsible Party: Maria de la Concepción Valdivia Alarcón, "Heroes del Moncada" Polyclinic
ClinicalTrials.gov Identifier: NCT01043367     History of Changes
Other Study ID Numbers: CAT-0908-CU
Study First Received: January 5, 2010
Last Updated: March 6, 2011
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Depression
Dietary supplement
Deprexil

Additional relevant MeSH terms:
Depression
Depressive Disorder
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014