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Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression (SAMS)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00532103
First received: September 18, 2007
Last updated: September 19, 2008
Last verified: September 2008
  Purpose

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
Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Suicide Assessment Methodology Study (SAMS)

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Fifteen primary care and specialty care clinics across the country.

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

  • 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.
  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: NCT00532103

Locations
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
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Madhukar H. Trivedi, M.D., The University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00532103     History of Changes
Other Study ID Numbers: N01 MH90003-01, DSIR AT
Study First Received: September 18, 2007
Last Updated: September 19, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Suicidal Ideation
Major Depressive Disorder
Suicide Risk
Antidepressant Medication

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mental Disorders
Mood Disorders
Self-Injurious Behavior
Suicide

ClinicalTrials.gov processed this record on November 24, 2014