Clinical trial NCT00735670: Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
Official title: Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: SCI
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2008-08-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
timeFrame: Baseline and Week 13
Secondary outcomes:
measure: Depression Scale of the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Model SCI Care System
state: Michigan
Study officials:
affiliation: University of Michigan Department of Physical Medicine and Rehabilitation
name: Denise G Tate, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Anthony Chiodo, M.D.
role: STUDY_DIRECTOR
References: