A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise

Completed · Phase 4

Conditions studied: Depression, Depressive Disorder, Major, Depressive Disorder, Unipolar Depression, Major Depressive Disorder

In brief

This pilot study aims to test a model that predicts that enhanced neurotransmitter gamma-aminobutyric acid (GABA) function in reward and affect-regulation central nervous system (CNS) circuits mediates the antidepressant effects of exercise. State-of-the-art magnetic resonance (MR) imaging, cognitive assessment, accelerometry, genetic, and inflammatory biomarkers will be acquired through the coordination of efforts from several established research programs at Western Psychiatric Institute and Clinic. This pilot study will be used as a platform for testing a causal/mediating role of GABA interneurons in reward processing and affect regulation in humans. This pilot study is not powered for testing a full causal model, but rather is intended to test overall feasibility of the intervention and acquisition of measures (see specific aim 1 below). This is a necessary prerequisite for designing a larger more definitive study of the model, which will be a component of a future grant application. Additionally, the data from this study will be used to test the clinical efficacy of exercise as an adjunctive treatment for late life depression (LLD; Specific Aim 2), as well as imaging, cognitive, and sleep aims (Specific Aims 3 and 4).

Key facts

Study ID

NCT02407704

Run by

Kirk Erickson, PhD

People needed

31

Starts

2015-03-01

Expected to finish

2016-12-01

Last updated by the study team

2018-05-23

Who can join

Age: 60 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 20-39 (recruitment complete) and 60-79 years old (open to recruitment)
• Major depressive disorder (MDD), single or recurrent, as diagnosed by the PRIME-MD
• MADRS ≥ 15
• In-town and available to commute to Oakland for a 12-week period
• Study nurse practitioner approval to participate in a 12-week moderate intense exercise intervention
• Eligible to undergo MRI

You may not qualify if…

• Inability to provide informed consent.
• Modified Mini-Mental Score (3MS) less than 84 or dementia based upon Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria including poor performance on the clinical neuropsychological battery, IQCODE, and all available clinical information.
• Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
• Abuse of or dependence on alcohol or other substances within the past three months
• High risk for suicide [e.g., active suicidal ideation (SI) and/or current/recent intent or plan] AND unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). Urgent psychiatric referral will be made in these cases.
• Contraindication to venlafaxine XR as determined by study physician including history of intolerance of venlafaxine XR in the study target dosage range (venlafaxine XR at up to 300 mg/day).
• Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English).
• Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
• Unstable/uncontrolled medical illness, including delirium, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.
• Subjects taking psychotropic medications that cannot be safely tapered or discontinued prior to study initiation
• If a patient failed a trial of venlafaxine (12 weeks of treatment with venlafaxine including at least 6 weeks on 300mg/day), he/she would not be eligible.
• Other drugs that may affect the GABA system will be excluded (e.g., Kava, Valerian, Theanine, and GABA supplements).
• The drug Linezolid (Zyvox) should be discontinued prior to study enrollment and should not be used during the study.
• Exclusion criteria for MR scans include: cardiac pacemaker, aneurysm clip, cochlear implant, pregnancy, intrauterine device, shrapnel, history of metal fragments in the eye, neurostimulators, weight >250 lbs., tinnitus, or claustrophobia.
• Current medical condition or treatment for a medical condition that could affect balance, gait, or contraindicate participation in moderate intensity physical activity.
• Observed gait condition or use of walking assisted device that would contraindicate use of treadmill for exercise testing and intervention.
• Current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event; within the previous 12 months having a myocardial infarction, coronary artery bypass grafting, or angioplasty; conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT).
• Eating disorders that would contraindicate physical activity.
• Report exercise on more than three days per week for greater than 20 minutes per day over the past three months.
• Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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