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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00735670
First received: August 14, 2008
Last updated: March 2, 2011
Last verified: January 2011
  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.


Condition Intervention Phase
Spinal Cord Injury
Drug: Venlafaxine HCI
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Assessed at baseline, weekly from weeks 1-5, week 9 at the end of treatment and then 3 months (week13) and after another 12 months (week26) ] [ Designated as safety issue: No ]
    This is a brief measure of depression taking 3-5 minutes to complete used to measure outcome and assess changes in mood during the study protocol times (before and after durg treatemnt). The PHQ-9 queries respondents about the occurrence of 9 symptoms of depression at baseline before the treatment started, and then by weeks 1-3,5,9, 13 (outcome), 14-16, 18, 20 and finally in week 26 (outcome) . The PHQ-9 has acceptable sensitivity and specificity.

  • The Beck Scale for Suicide Ideation (BSS) [ Time Frame: same as PHQ-9 ] [ Designated as safety issue: Yes ]
    The BSS is used to assess the presence and severity of suicidal thoughts. Two items in particularly are used to assess safety during trial by assessing both active and passive suicidality.

  • 16 item Quick Inventory of Depressive Symptomatology (QIDS- SR16) [ Time Frame: Baseline; weeks 13 and 26 ] [ Designated as safety issue: No ]
    It assesses depression symptoms across the nine DSM-IV criterion domians. It is a primary measure of the extent of depressive symptomatology.


Secondary Outcome Measures:
  • The SCI Pain Instrument (SCIPI) [ Time Frame: Baseline; weeks 13 and 26 ] [ Designated as safety issue: No ]
    is a 14 item instrument designed for assessment of both the intensity of pain as a sensory experience and the degree to which pain interferes with function.

  • The Adherence and Side Effects Checklist [ Time Frame: Same as PHQ-9 ] [ Designated as safety issue: Yes ]
    Monitors medication adherence and keeps track of side effects of the study drug

  • CAGE & Drug Use [ Time Frame: Same as PHQ-9 ] [ Designated as safety issue: Yes ]
    Is used to conduct safety monitoring with respect to subject using drugs and/or alcohol during treatment; and is also used to screen subjects eligible for the study.

  • Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline; weeks 13 and 26 ] [ Designated as safety issue: No ]
    It is a 7 item measure to assess generalized anxiety and it is criterion refernced in relation to the DSM-IV. The GAD will be used as a secondary outcome measure.

  • The Perceived Stress Scale (PSS) [ Time Frame: baseline, 13 and 26 weeks ] [ Designated as safety issue: No ]
    This is a 14 item measure to assess the degree to which life events are considered stressful.

  • Life Experiences Survey - Disability (LES-D) [ Time Frame: baseline; 13 and 26 weeks ] [ Designated as safety issue: No ]
    This measures the nature of life events during the previous year; what happens to respondents and their perceptions.

  • The Received Social Support and Social Undermining Scale (RSS/SU) [ Time Frame: baseline; 13 and 26 weeks ] [ Designated as safety issue: No ]
    The items concern how the significant people in the respondent's life nehave towards them.

  • Measure of the Quality of the Environment [ Time Frame: baseline; 13 and 26 weeks ] [ Designated as safety issue: No ]
    It is a 26 item questionnaire of the perceived quality of environmental influences on community particpation.

  • The Perceived Handicap Questionnaire (PHQ) [ Time Frame: baseline; 13 and 26 weeks ] [ Designated as safety issue: No ]
    It asks the respondents about their relative abilities in the areas of physical independence, mobility, occupation, social integration and economic self-sufficiency.

  • Craig Handicap Assessment and Reporting Form - Short Form (CHART-SF) [ Time Frame: baseline; 13 and 26 weeks ] [ Designated as safety issue: No ]
    Only the Occupational scale of the CHART-SF will be used to measure types of productive activities after comminity re-entry.

  • The SF-12 Health Status Questionnaire - 12 [ Time Frame: baseline; 13 and 26 weeks ] [ Designated as safety issue: No ]
    The SF-12 measures health related quality of life including items from various domains, physical, functional, psychological, pain, etc.


Estimated Enrollment: 16
Study Start Date: June 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects will be provided with the medication starting at 37.5 mg and ending at 150 mg. for 13 weeks when they start titrating down back to 75mg at 13 weeks and 37.5 mg at 15 weeks. They receive no drugs from weeks 16th to 26ths when the study ends.There are 13 assessments and data collection points for this study. These include 3 face to face assessments at baseline, 13 weeks and 26 weeks. Additional contacts will be done via telephone calls.
Drug: Venlafaxine HCI
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 Name: Effexor XR
Placebo Comparator: B
Subjects will receive a placebo instead of medication with all other conditions being the same including placebo doses. The study drug or placebo will be dispensed following this same schedule by IDS eight times per study subject. This may vary slightly depending on response to treatment, etc.
Other: Placebo
Subjects will receive a placebo instead of drug for 6 months during the duration of treatment

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735670

Contacts
Contact: Linda Berlin, MA (734) 763-0971 lspencer@umich.edu
Contact: Linton Cuff, MA (734) &63-0971 lintoncu@umich.edu

Locations
United States, Michigan
University of Michigan Model SCI Care System Recruiting
Ann Arbor, Michigan, United States, 48109-5491
Contact: Linda Berlin, MA    734-763-0971    lspencer@umich.edu   
Contact: Linton Cuff, MA    (734) 763-0971    lintoncu@umich.edu   
Principal Investigator: Denise Tate, Ph.D.         
Principal Investigator: Anthony Chiodo, MD         
Sub-Investigator: Gianna Rodriguez, MD         
Sub-Investigator: Claire Kalpakjian, Ph.D.         
Sub-Investigator: Marty Forchheimer, MPP         
Sub-Investigator: Juan Lopez, MD         
Sub-Investigator: Jon Kar Zubieta, MD, Ph.D.         
Sub-Investigator: Michelle Meade, Ph.D.         
Sponsors and Collaborators
University of Michigan
U.S. Department of Education
Investigators
Principal Investigator: Anthony Chiodo, M.D. University of Michigan Department of Physical Medicine and Rehabilitation
  More Information

Additional Information:
No publications provided

Responsible Party: Denise G Tate, Ph.D., Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00735670     History of Changes
Other Study ID Numbers: NDNO60032SS, NIDRRH133N060032
Study First Received: August 14, 2008
Last Updated: March 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
SCI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Spinal Cord Injuries
Wounds and Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014