Deprexil in Subjects With Signs and Symptoms of Depression

NCT ID: NCT01043367

Last Updated: 2011-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Deprexil

Group Type EXPERIMENTAL

Deprexil

Intervention Type DIETARY_SUPPLEMENT

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.

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catalysis SL

INDUSTRY

Sponsor Role lead

Responsible Party

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"Heroes del Moncada" Polyclinic

Principal Investigators

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Maria de la Concepción Valdivia Alarcón, MD

Role: PRINCIPAL_INVESTIGATOR

"Heroes del Moncada" Polyclinic

Locations

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"Heroes del Moncada" Polyclinic

Havana, La Habana, Cuba

Site Status

Countries

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Cuba

Other Identifiers

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CAT-0908-CU

Identifier Type: -

Identifier Source: org_study_id

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