Deprexil in Subjects With Signs and Symptoms of Depression

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01043367

Enrollment

200

Registered

2010-01-06

Start date

2010-01-31

Completion date

2011-01-31

Last updated

2011-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Dietary supplement, Deprexil

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.

Interventions

DIETARY_SUPPLEMENTDeprexil

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.

DIETARY_SUPPLEMENTPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Cuba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026