Deprexil in Subjects With Signs and Symptoms of Depression

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Deprexil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01043367

CAT-0908-CU

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Deprexil

Treatment:

Dietary Supplement: Deprexil

B

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo