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Deprexil in Subjects With Signs and Symptoms of Depression

Primary Purpose

Depression

Status

Completed

Phase

Phase 3

Locations

Cuba

Study Type

Interventional

Intervention

Deprexil

Placebo

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Dietary supplement, Deprexil

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

"Heroes del Moncada" Polyclinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Deprexil

Placebo

Outcomes

Primary Outcome Measures

Functional capabilities at week 24 (end of the treatment)

Social capabilities at week 24 (end of the treatment)

Psycho-affective capabilities at week 24 (end of the treatment)

Behavioral capabilities at week 24 (end of the treatment)

Secondary Outcome Measures

Tolerability to Deprexil at week 24 (end of the treatment)

Symptoms of depression at week 24 (end of the treatment)

Signs of depression at week 24 (end of the treatment)

Clinical symptoms of baseline disease at 24 weeks (end of the treatment)

Full Information

NCT ID

NCT01043367

First Posted

January 5, 2010

Last Updated

March 6, 2011

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT01043367

Brief Title

Deprexil in Subjects With Signs and Symptoms of Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Catalysis SL

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression, Dietary supplement, Deprexil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Deprexil

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Deprexil

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Functional capabilities at week 24 (end of the treatment)

Time Frame

24 weeks

Title

Social capabilities at week 24 (end of the treatment)

Time Frame

24 weeks

Title

Psycho-affective capabilities at week 24 (end of the treatment)

Time Frame

24 weeks

Title

Behavioral capabilities at week 24 (end of the treatment)

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Tolerability to Deprexil at week 24 (end of the treatment)

Time Frame

24 weeks

Title

Symptoms of depression at week 24 (end of the treatment)

Time Frame

24 weeks

Title

Signs of depression at week 24 (end of the treatment)

Time Frame

24 weeks

Title

Clinical symptoms of baseline disease at 24 weeks (end of the treatment)

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria de la Concepción Valdivia Alarcón, MD

Organizational Affiliation

"Heroes del Moncada" Polyclinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

"Heroes del Moncada" Polyclinic

City

Havana City

State/Province

Havana

ZIP/Postal Code

10400

Country

Cuba

12. IPD Sharing Statement

Learn more about this trial

Deprexil in Subjects With Signs and Symptoms of Depression

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