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

NCT ID: NCT00735670

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-08-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Venlafaxine

Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.

Group Type: EXPERIMENTAL

Venlafaxine HCl

Intervention Type: 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

Placebo

Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Venlafaxine HCl

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Effexor XR

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Denise Tate

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denise G Tate, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Department of Physical Medicine and Rehabilitation

Anthony Chiodo, M.D.

Role: STUDY_DIRECTOR

University of Michigan

Locations

University of Michigan Model SCI Care System

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

NIDRRH133N060032

Identifier Type: -

Identifier Source: secondary_id

NDNO60032SS

Identifier Type: -

Identifier Source: org_study_id