Skip to main content
OpenTrials
Completed

NCT Number: NCT01043367

Deprexil 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

"Heroes del Moncada" Polyclinic

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEPREXIL

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.

Placebo

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.

Primary outcomes

  1. Functional capabilities at week 24 (end of the treatment)

    Time frame: 24 weeks

  2. Social capabilities at week 24 (end of the treatment)

    Time frame: 24 weeks

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

    Time frame: 24 weeks

  4. Behavioral capabilities at week 24 (end of the treatment)

    Time frame: 24 weeks

Secondary outcomes

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 6, 2010
Registry last updated
Mar 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.