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

September 19, 2008 updated by: National Institute of Mental Health (NIMH)

Suicide Assessment Methodology Study (SAMS)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
        • Tuscalossa VA Mental Health Clinic
    • California
      • Harbor City, California, United States, 90710
        • Harbor UCLA Family Health Care Center
      • Los Angeles, California, United States, 90024
        • UCLA Internal Medicine Clinic
      • San Diego, California, United States, 92161
        • Veterans Affairs Medical Center/FIRM Primary Care Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Psychiatric Outpatient Treatment Care Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Clinical Research Institute
    • Massachusetts
      • Salem, Massachusetts, United States, 01970
        • MGH/Northshore Medical Center (Salem Psychiatric Facility)
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • General Psychiatric Ambulatory Clinic
    • New York
      • New York, New York, United States, 11040
        • Irving Goldman Primary Care at North Shore Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7160
        • UNC Chapel Hill Adult Diagnostic & Treatment Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Laureate Psychiatric Clinic and Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Bellefield Clinic of WPIC
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vine Hill Community Clinic
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Family Medicine Clinic
    • Virginia
      • Richmond, Virginia, United States, 23298
        • VCU Outpatient Psychiatry Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Fifteen primary care and specialty care clinics across the country.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria

September 18, 2007

First Posted (Estimate)

September 19, 2007

Study Record Updates

Last Update Posted (Estimate)

September 22, 2008

Last Update Submitted That Met QC Criteria

September 19, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 MH90003-01
  • DSIR AT (NCT00590863)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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