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

NCT00735670 | Completed Results DMC

• 2 other identifiers: NDNO60032SSNIDRRH133N060032
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

SCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Depression Scale of the Patient Health Questionnaire (PHQ-9)

  Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks

Study Arms (2)

Venlafaxine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Venlafaxine HCl 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

Also known as: Effexor XR

Venlafaxine

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• U.S. Department of Education: collaborator

Study Sites (1)

University of Michigan Model SCI Care System

Ann Arbor, Michigan, 48109-5491, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Limitations and Caveats

Difficulties with recruitment and high rate of withdrawal (57%) resulted in a very small sample. As such, results must be taken with caution given low power in this study.

Results Point of Contact

• Title: Dr. Denise G Tate
• Organization: University of Michigan Spinal Cord Injury System

dgtate@umich.edu

734 763-0971

Study Officials

• Denise G Tate, Ph.D.

  University of Michigan Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Anthony Chiodo, M.D.

  University of Michigan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 13, 2016
• Results First Posted: October 13, 2016

Record last verified: 2016-10

Locations

US (1)