At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 31 enrolled

Drug / intervention

Venlafaxine XR +2 moredrug

Likely dose

Lorazepam 2mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02407704

NCT02407704Phase 4Completed

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

Kirk Erickson, PhD·interventional·Posted Apr 3, 2015·Updated May 23, 2018

In Brief

A Phase 4 clinical trial evaluating Venlafaxine XR, Aerobic Exercise, and 1 other intervention for Depression and 4 related conditions. Completed, enrolled 31 participants across 1 site.

Detailed Summary

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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDepression, Depressive Disorder, Major, Depressive Disorder, Unipolar Depression, Major Depressive Disorder

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartMar 2015

First PostedApr 2015

Primary CompletionNov 2016

Study CompletionDec 2016

TodayJul 2026

First PostedApr 3, 2015

Enrollment StartMar 1, 2015

Primary CompletionNov 1, 2016

Study CompletionDec 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 11.2 years ago

Interventions

Venlafaxine XRdrug

Aerobic Exerciseother

Lorazepamdrug

Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.