N/A
N=126
Adding Exercise to Antidepressant Medication Treatment for Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00076258 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated) — 18; 18 percentage of participants in remission — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SSRI + LD (Behavioral); SSRI + PHD (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated) |
18; 18 | <0.05 sig |
Summary
This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Major Depressive Disorder
- Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
- 8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
- Sedentary lifestyle
- Physically capable of exercise
- Body mass index (BMI) less than 40 kg/m2
- Willing and able to comply with study requirements
Exclusion Criteria
- Significant cardiovascular disease or other medical conditions
- Uncontrolled hypertension
- Abnormal exercise stress test
- Hematologic disorders
- Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
- Alcohol and/or substance abuse in the past 6 months
- Hospitalization for mental illness within the past year
- High suicide risk
- Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
- Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
- Significantly elevated blood lipids
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00076258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.