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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Drug: Venlafaxine HCl; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5491
      • University of Michigan Model SCI Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: 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; Other Names: Effexor XR
PLACEBO_COMPARATOR: 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.	Other: Placebo; Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)	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).	Baseline and Week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Scale of the Patient Health Questionnaire (PHQ-9)	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.	Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: Denise G Tate, Ph.D., University of Michigan Department of Physical Medicine and Rehabilitation; Study Director: Anthony Chiodo, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: August 14, 2008
• First Submitted That Met QC Criteria: August 14, 2008
• First Posted (ESTIMATE): August 15, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: SCI
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: NDNO60032SS; NIDRRH133N060032