At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 263 enrolled

Drug / intervention

Higher-dose venlafaxine +2 moredrug

Likely dose

Higher-dose venlafaxine 300 mgfrom 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/NCT01124188

NCT01124188Phase 4Completed

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Optimizing Care for Older Adults With Back Pain and Depression

University of Pittsburgh·interventional·Posted May 14, 2010·Updated May 12, 2017

In Brief

A Phase 4 clinical trial evaluating Higher-dose venlafaxine, Supportive management, and 1 other intervention for Depression and Back Pain. Completed, enrolled 263 participants across 1 site.

Detailed Summary

The primary question addressed by this study is: Using a stepped care approach in primary care, what is the value of the combination of an antidepressant medication (Venlafaxine) and psychotherapy for seniors living with depression and chronic lower back pain when treatment with a low-dose of venlafaxine and supportive management (SM) has led to only a partial or non-response?

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDepression, Back Pain

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartMay 2010

First PostedMay 2010

Primary CompletionFeb 2016

TodayJul 2026

First PostedMay 14, 2010

Enrollment StartMay 1, 2010

Primary CompletionFeb 1, 2016

TodayJul 2, 2026

Enrollment to primary: 5.8 yearsPosted 16.1 years ago

Interventions

Higher-dose venlafaxinedrug

Dosing of venlafaxine will range from 187.5-300 mg/day.

Supportive managementbehavioral

Supportive management encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.

Problem Solving Therapy for Depression and Painbehavioral

PST-DP will be delivered over the course of 10 sessions over 14 weeks. Along with teaching the participant 7 steps of problem solving, PST-DP also includes a medication support and management component.