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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00532103
Date of registration: 18/09/2007
Primary sponsor: National Institute of Mental Health (NIMH)
Public title: Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression SAMS
Scientific title: Suicide Assessment Methodology Study (SAMS)
Date of first enrolment: July 2007
Target sample size: 300
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00532103
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
United States
Contacts
Name:   Stephen R. Wisniewski, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Pittsburgh
Name:   David W. Morris, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Texas Southwestern Medical Center
Name:   Diane Warden, PhD, MBA
Address: 
Telephone:
Email:
Affiliation:  University of Texas Southwestern Medical Center
Name:   Kathy Shores-Wilson, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Texas Southwestern Medical Center
Name:   Madhukar Trivedi, MD
Address: 
Telephone:
Email:
Affiliation:  University of Texas Southwestern Medical Center
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Depression
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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