Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression (SAMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00532103|
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : September 22, 2008
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|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Suicide Assessment Methodology Study (SAMS)|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY
- Patients must be enrolled at the primary or specialty care site, and be planning to continue living in the area of that clinic throughout the study
- Patients must be 18-75 years old
- Patients must meet clinical criteria for MDD, based on clinical interview and DSM IV MDD checklist
- Screening HAM-D17 score greater than or equal to 14
- Patients must give written informed consent
- Patients with and without current suicidal ideation may be included in the study
- Patients must not have taken antidepressant medication for at least 2 weeks prior to screen (or 4 weeks in the case of fluoxetine).
- Current substance abuse or dependence
- Two past SSRI treatment failures within the current episode, or last 2 years if chronic.
- Patients with a current Axis I diagnosis of Bipolar disorder or Schizophrenia
- Patients with a current Primary Axis I diagnosis of Obsessive-Compulsive disorder, Anorexia Nervosa or Bulimia.
- Women who are sexually active and who are not using adequate contraception, or who are pregnant, trying to become pregnant, or breast feeding.
- Patients with general medical conditions that contraindicate antidepressant medications
- Patients whose clinical status requires inpatient treatment at the time of baseline interview.
- Patients who cannot read and understand English since all research instruments are not yet translated and validated in Spanish or other languages.
- Some reports of SSRI-induced akathisia-like states have found them to be more highly correlated with either concurrent or previous treatment with a neuroleptic, even in patients with no history of movement disorders therefore, patients who have taken an anti-psychotic medication within 4 months of the screening visit will be excluded from the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532103
|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:||Madhukar H. Trivedi, M.D., The University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||September 19, 2007 Key Record Dates|
|Last Update Posted:||September 22, 2008|
|Last Verified:||September 2008|
Major Depressive Disorder