Major Depressive Disorder Clinical Trial
— PEXATOfficial title:
Efficacy of Exercise as an Adjunct Treatment for Clinically Depressed Inpatients During the Initial Stages of Antidepressant Therapy.
35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (control group; NI). The intervention length was 10 consecutive days. In groups 1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day. Depressive symptoms were assessed the day before the beginning of intervention and the day after the end of intervention for participants of both groups.
Status | Completed |
Enrollment | 48 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - diagnosis of major depressive disorder (MDD) - antidepressant drug therapy initiated for less than 2 weeks - score of 29 or more on the Beck depression inventory Exclusion Criteria: - medical contraindication for exercise practice - inability to understand written French - beta-blocking drugs or another forms of antidepressant therapy (sleep deprivation, electroconvulsive therapy) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Université de Reims Champagne-Ardenne |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score change on the 21-item Beck depression inventory (BDI-II). Each item has a set of severity-graded self-evaluative statements that are rated 0 (neutral) to 3 (maximum severity). | Baseline and 10 days | No |
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