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NCT01124188 · ClinicalTrials.gov registry record · Phase 4
ADAPT: Addressing Depression and Pain Together
A Phase 4 study of Depression and Back Pain, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 263
- Enrollment target
- 1
- Study location
NCT01124188: Completed Phase 4 study of Depression and Back Pain, sponsored by University of Pittsburgh.
NCT01124188 is a Phase 4 study of Depression and Back Pain that has completed, run by University of Pittsburgh. The registered enrollment target is 263 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01124188, a Phase 4 study of Depression and Back Pain, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 263 participants
- Enrollment target
- 1
- Study location
Study 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?
Primary Outcome
The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores \< or = to 5 AND Numeric Rating Scale for pain (NRS) \> or = 30% reduction from study entry.
Conditions Studied
Interventions
- DRUG Higher-dose venlafaxine
- BEHAVIORAL Supportive management
- BEHAVIORAL Problem Solving Therapy for Depression and Pain
Study Locations (1)
Pennsylvania
- University of Pittsburgh Late Life Depression Program - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2010-05 |
| Est. Completion | 2016-02 |
| Phase | Phase 4 |
What the finished NCT01124188 record still lists
NCT01124188 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Higher-dose venlafaxine is the first listed.
NCT01124188 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01124188 about?
NCT01124188 is a clinical study titled "ADAPT: Addressing Depression and Pain Together". 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 venlaf...
What is the current status of trial NCT01124188?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 263 participants. The study started on 2010-05. Estimated completion is 2016-02.
What conditions does trial NCT01124188 study?
This clinical trial studies the following conditions: Depression, Back Pain.
What interventions are being tested in trial NCT01124188?
The interventions under investigation include: Higher-dose venlafaxine (DRUG), Supportive management (BEHAVIORAL), Problem Solving Therapy for Depression and Pain (BEHAVIORAL).
Who is sponsoring clinical trial NCT01124188?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01124188 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01124188's enrollment target sits among peer trials
263 169th of 679 higher than 511 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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