N/A N=21 Randomized Triple-blind Treatment

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

Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT00735670 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Oct 2016

Primary outcome: Primary: 16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16) — 2; 0 participants — p=0.445

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Venlafaxine HCl (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY 16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)	2; 0	0.445
SECONDARY Depression Scale of the Patient Health Questionnaire (PHQ-9)	4.84; 5.46; 8.9; 10.36; 7; 9.67	0.725

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00735670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.