Deprexil in Subjects With Signs and Symptoms of Depression

March 6, 2011 updated by: Catalysis SL

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba, 10400
        • "Heroes del Moncada" Polyclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional capabilities at week 24 (end of the treatment)
Time Frame: 24 weeks
24 weeks
Social capabilities at week 24 (end of the treatment)
Time Frame: 24 weeks
24 weeks
Psycho-affective capabilities at week 24 (end of the treatment)
Time Frame: 24 weeks
24 weeks
Behavioral capabilities at week 24 (end of the treatment)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability to Deprexil at week 24 (end of the treatment)
Time Frame: 24 weeks
24 weeks
Symptoms of depression at week 24 (end of the treatment)
Time Frame: 24 weeks
24 weeks
Signs of depression at week 24 (end of the treatment)
Time Frame: 24 weeks
24 weeks
Clinical symptoms of baseline disease at 24 weeks (end of the treatment)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Maria de la Concepción Valdivia Alarcón, MD, "Heroes del Moncada" Polyclinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (ESTIMATE)

January 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 6, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0908-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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