Ann Arbor, Michigan 48109


Purpose:

This study proposes to test the efficacy of Venlafaxine HCI in reducing mild to moderate symptoms of depression among persons with Spinal Cord Injury (SCI). This study recruits either traumatic or non-traumatic injured persons with SCI living in the community.


Study summary:

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. As a secondary outcome, this study will assess also the benefits of this medication in reducing severity of symptoms of pain, and enhancing subjects' perceived health and participation in the community. 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.


Criteria:

Inclusion Criteria: - Having incurred a SCI at least one year prior to enrollment - Neurological impairment ASIA Grades A-D with some associated functional limitations - PHQ 9 scores of 5 - 14 (mild to moderate symptom severity) - English speaker - Age 18 years or older - Completed informed consent and agreement to release protected health information (PHI) under the rules established by HIPAA - Able to communicate with study personnel Exclusion Criteria: - 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 - Presence of glaucoma - Engagement in another experimental study within 30 days - Expectation of major surgery within the following 12 weeks


NCT ID:

NCT00735670


Primary Contact:

Principal Investigator
Anthony Chiodo, M.D.
University of Michigan Department of Physical Medicine and Rehabilitation

Linda Berlin, MA
Phone: (734) 763-0971
Email: lspencer@umich.edu


Backup Contact:

Email: lintoncu@umich.edu
Linton Cuff, MA
Phone: (734) &63-0971


Location Contact:

Ann Arbor, Michigan 48109
United States

Linda Berlin, MA
Phone: 734-763-0971
Email: lspencer@umich.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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