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


Study is Available At:


Original ID:

NDNO60032SS


NCT ID:

NCT00735670


Secondary ID:

NIDRRH133N060032


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Anthony Chiodo, M.D.
Principal Investigator
University of Michigan Department of Physical Medicine and Rehabilitation
Primary Contact:Linda Berlin, MA
(734) 763-0971
lspencer@umich.edu
Backup Contact:Linton Cuff, MA
(734) &63-0971
lintoncu@umich.edu

Study Dates

Start Date:June 2008
Completion Date:August 2011
Completion Type:Anticipated
Primary Completion Date:June 2011
Primary Completion Type:Anticipated
Verification Date:January 2011
Last Changed Date:March 2, 2011
First Received Date:August 14, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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 (week
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:The Beck Scale for Suicide Ideation (BSS)
Time Frame:same as PHQ-9
Safety Issues:True
Description: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.
Outcome Type:Primary Outcome
Measure:16 item Quick Inventory of Depressive Symptomatology (QIDS- SR16)
Time Frame:Baseline; weeks 13 and 26
Safety Issues:False
Description:It assesses depression symptoms across the nine DSM-IV criterion domians. It is a primary measure of the extent of depressive symptomatology.
Outcome Type:Secondary Outcome
Measure:The SCI Pain Instrument (SCIPI)
Time Frame:Baseline; weeks 13 and 26
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:The Adherence and Side Effects Checklist
Time Frame:Same as PHQ-9
Safety Issues:True
Description:Monitors medication adherence and keeps track of side effects of the study drug
Outcome Type:Secondary Outcome
Measure:CAGE & Drug Use
Time Frame:Same as PHQ-9
Safety Issues:True
Description: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.
Outcome Type:Secondary Outcome
Measure:Generalized Anxiety Disorder-7 (GAD-7)
Time Frame:Baseline; weeks 13 and 26
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:The Perceived Stress Scale (PSS)
Time Frame:baseline, 13 and 26 weeks
Safety Issues:False
Description:This is a 14 item measure to assess the degree to which life events are considered stressful.
Outcome Type:Secondary Outcome
Measure:Life Experiences Survey - Disability (LES-D)
Time Frame:baseline; 13 and 26 weeks
Safety Issues:False
Description:This measures the nature of life events during the previous year; what happens to respondents and their perceptions.
Outcome Type:Secondary Outcome
Measure:The Received Social Support and Social Undermining Scale (RSS/SU)
Time Frame:baseline; 13 and 26 weeks
Safety Issues:False
Description:The items concern how the significant people in the respondent's life nehave towards them.
Outcome Type:Secondary Outcome
Measure:Measure of the Quality of the Environment
Time Frame:baseline; 13 and 26 weeks
Safety Issues:False
Description:It is a 26 item questionnaire of the perceived quality of environmental influences on community particpation.
Outcome Type:Secondary Outcome
Measure:The Perceived Handicap Questionnaire (PHQ)
Time Frame:baseline; 13 and 26 weeks
Safety Issues:False
Description:It asks the respondents about their relative abilities in the areas of physical independence, mobility, occupation, social integration and economic self-sufficiency.
Outcome Type:Secondary Outcome
Measure:Craig Handicap Assessment and Reporting Form - Short Form (CHART-SF)
Time Frame:baseline; 13 and 26 weeks
Safety Issues:False
Description:Only the Occupational scale of the CHART-SF will be used to measure types of productive activities after comminity re-entry.
Outcome Type:Secondary Outcome
Measure:The SF-12 Health Status Questionnaire - 12
Time Frame:baseline; 13 and 26 weeks
Safety Issues:False
Description:The SF-12 measures health related quality of life including items from various domains, physical, functional, psychological, pain, etc.

Study Interventions

Intervention Type:Drug
Name:Venlafaxine HCI
Description: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
Arm Name:A
Other Name:Effexor XR
Intervention Type:Other
Name:Placebo
Description:Subjects will receive a placebo instead of drug for 6 months during the duration of treatment
Arm Name:B

Study Arms

Study Arm Type:Experimental
Arm Name:A
Description: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.
Study Arm Type:Placebo Comparator
Arm Name:B
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:U.S. Department of Education

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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