N/A Completed N=126 Randomized Single-blind Treatment

Adding Exercise to Antidepressant Medication Treatment for Depression

Depression

Source: ClinicalTrials.gov NCT00076258 ↗

Enrolled (actual)

126

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcomePrimary: 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

Summary

This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).

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

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

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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. Informational only — not medical advice.