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Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) Depression Trials Network |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00532103 |
This study will develop a new methodology to evaluate any treatment-emergent suicidal ideation that might occur when an antidepressant treatment has been started and/or during times when doses are increased in patients with major depressive disorder.
Condition |
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Depression |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Suicide Assessment Methodology Study (SAMS) |
Estimated Enrollment: | 300 |
Study Start Date: | July 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
This is a pilot study to begin to develop a measurement procedure to help guide the clinical management of suicide risk in people beginning a type of antidepressant medication called a selective serotonin reuptake inhibitor (SSRI). The goals of the study are: 1) to identify the best method and assessment measures to evaluate the severity of suicidal ideation, 2) to determine the appropriate frequency and duration of assessment required to adequately evaluate this suicidal ideation, 3) to evaluate the presence of symptoms that are associated with suicidal ideation (such as anxiety, panic attacks, difficulty in sleeping) and 4) to identify the most critical time periods during which suicidal ideation appears or worsens (such as how long after initiation of treatment or dosage increase).
In all, 300 adult participants with major depressive disorder (MDD), between the ages of 18 and 75, may be enrolled at primary and psychiatric care sites across the US. All patients will be treated with an SSRI for eight weeks. The choice of SSRI used in treatment will be chosen by the study physician at each site. For this study, physicians will choose from the following six SSRIs: citalopram, escitalopram, sertraline, paroxetine, paroxetine-CR, and fluoxetine. Patients beginning an SSRI for MDD in "real world" psychiatric and primary care settings, will have clinic visits and receive evaluations of their symptoms of depression, side effects, suicidal thinking and symptoms that are thought to be associated with suicidal risk, every other week for eight weeks. They will be evaluated by phone for symptoms and side effects each week they do not come to the clinic. They will also receive phone calls three times a week for the first two weeks of the study, after beginning the antidepressant, and after a dose increase to evaluate suicide risk.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Fifteen primary care and specialty care clinics across the country.
Inclusion Criteria:
ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY
Exclusion Criteria:
United States, Alabama | |
Tuscalossa VA Mental Health Clinic | |
Tuscaloosa, Alabama, United States, 35404 | |
United States, California | |
Harbor UCLA Family Health Care Center | |
Harbor City, California, United States, 90710 | |
UCLA Internal Medicine Clinic | |
Los Angeles, California, United States, 90024 | |
Veterans Affairs Medical Center/FIRM Primary Care Clinic | |
San Diego, California, United States, 92161 | |
United States, Illinois | |
Northwestern Psychiatric Outpatient Treatment Care Center | |
Chicago, Illinois, United States, 60611 | |
United States, Kansas | |
Clinical Research Institute | |
Wichita, Kansas, United States, 67214 | |
United States, Massachusetts | |
MGH/Northshore Medical Center (Salem Psychiatric Facility) | |
Salem, Massachusetts, United States, 01970 | |
United States, Michigan | |
General Psychiatric Ambulatory Clinic | |
Ann Arbor, Michigan, United States, 48105 | |
United States, New York | |
Irving Goldman Primary Care at North Shore Hospital | |
New York, New York, United States, 11040 | |
United States, North Carolina | |
UNC Chapel Hill Adult Diagnostic & Treatment Clinic | |
Chapel Hill, North Carolina, United States, 27599-7160 | |
United States, Oklahoma | |
Laureate Psychiatric Clinic and Hospital | |
Tulsa, Oklahoma, United States, 74135 | |
United States, Pennsylvania | |
Bellefield Clinic of WPIC | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Vine Hill Community Clinic | |
Nashville, Tennessee, United States, 37212 | |
United States, Texas | |
UT Southwestern Family Medicine Clinic | |
Dallas, Texas, United States, 75390 | |
United States, Virginia | |
VCU Outpatient Psychiatry Clinic | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Madhukar Trivedi, MD | University of Texas Southwestern Medical Center |
Study Director: | Stephen R. Wisniewski, PhD | University of Pittsburgh |
Study Director: | Diane Warden, PhD, MBA | University of Texas Southwestern Medical Center |
Study Director: | Kathy Shores-Wilson, PhD | University of Texas Southwestern Medical Center |
Study Director: | David W. Morris, PhD | University of Texas Southwestern Medical Center |
Responsible Party: | The University of Texas Southwestern Medical Center ( Madhukar H. Trivedi, M.D. ) |
Study ID Numbers: | N01 MH90003-01, DSIR AT |
Study First Received: | September 18, 2007 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00532103 History of Changes |
Health Authority: | United States: Federal Government |
Suicidal Ideation Major Depressive Disorder Suicide Risk Antidepressant Medication |
Depression Mental Disorders Mood Disorders Suicide |
Depressive Disorder, Major Depressive Disorder Antidepressive Agents Behavioral Symptoms |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |