Physical EXercise as an Adjunct Treatment for Depression

NCT02612142 | Completed

• 1 other identifier: EPSMM-2011
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

aerobic exercise (AE)

EXPERIMENTAL

Intervention type: Behavioral. Intervention name: Aerobic exercise Intervention description: 10 days of daily aerobic exercise (brisk walking, jogging); duration: 30 minutes per session; intensity: 65%-75% of age-predicted maximal heart rate. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day).

Behavioral: physical exercise

stretching exercise (ST)

SHAM COMPARATOR

Intervention type: Behavioral. Intervention name: Stretching exercise Intervention description: 10 days of daily stretching exercise; duration: 30 minutes per session. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day).

Behavioral: physical exercise

no intervention (NI)

NO INTERVENTION

No behavioral intervention. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day).

Interventions

physical exercise BEHAVIORAL

endurance-training or stretching (sham exercise)

aerobic exercise (AE); stretching exercise (ST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• medical contraindication for exercise practice
• inability to understand written French
• beta-blocking drugs or another forms of antidepressant therapy (sleep deprivation, electroconvulsive therapy)

Sponsors & Collaborators

• Université de Reims Champagne-Ardenne: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Exercise

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zodi Imad, MD

  Etablissement Public de Santé Mentale de la Marne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: June 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11