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Completed

NCT Number: NCT00735670

Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury

This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Model SCI Care System

Ann Arbor, Michigan, 48109-5491, United States

About this study

The successes of psychological and pharmacological modes of intervention in treating depression, both alone and combined, are well documented in the literature. While a great deal of research has identified specific clinical indications for many antidepressants currently available in the general population, little is known about the clinical indications of these agents in SCI. This study is proposed to test the benefits of Venlafaxine HCI (Effexor XR) for reducing mild to moderate symptoms of depression among people with SCI. The intervention will last 12 weeks and there will be 13 assessments and data collection points. Data will be collected at 26 weeks also. Eight face to face contacts are anticipated.

Because of the change in protocol to reducing mild to moderate symptoms and substantially lower enrollment than anticipated (1/6th of what we anticipated), we deleted a number of study outcomes listed in the 2011 posting of this study. Most of these were not part of the original posting in 2008, and those that were deleted were no longer relevant to new protocol's focus on reducing mild to moderate depression. The two outcomes reported here were most relevant to the revised protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having sustained an SCI at least six months prior to enrollment.
  • Neurological impairment ASIA Grades A-D.
  • Mild to moderate depressive symptoms.
  • English speaker
  • Age 18 years or older
  • Able to communicate with study personnel

Exclusion criteria

  • No neurological impairment due to SCI.
  • Presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools.
  • Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder).
  • Medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination).
  • Pregnant or unwilling to use birth control if female and sexually active.
  • Presence of glaucoma.
  • Prior use of study drug without success or being treated with another antidepressant medication and being unwilling to taper off to take the stud drug.
  • Willing to travel to Ann Arbor Michigan.
  • Expecting to take or currently taking another experimental study within 30 days
  • Major surgery scheduled within 12 weeks

Treatment and study plan

Venlafaxine HCl

Drug

Starting dose is 37.5 mg and ending dose is 150 mg at 13 weeks. From weeks 13 to 26 subjects no longer will receive the drug

Other names: Effexor XR

Placebo

Other

Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.

Primary outcomes

  1. 16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)

    Time frame: Baseline and Week 13

    The QIDS assesses symptoms of depression across the nine DSM-IV criterion domains for major depressive episode. The primary end-point in this study was the number of participants who had a >50% change in scores on the QIDs from baseline to week 13 (end of treatment period).

Secondary outcomes

  1. Depression Scale of the Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks

    The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Higher total scores indicate more severe symptomatology, ranging from 0 (no symptoms) to 27 (most severe symptoms). Data in the tables begin with the overall mean for each group that includes all subjects, average across all assessment time points. Each subsequent row reports the mean and standard deviation of each time point by allocation, noting sample size for each group in the arm/group title given missing data in each time point after baseline.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • U.S. Department of Education

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 15, 2008
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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