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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00532103 |
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Date of registration:
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18/09/2007 |
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Primary sponsor: |
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Public title:
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Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression
SAMS |
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Scientific title:
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Suicide Assessment Methodology Study (SAMS) |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00532103 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Stephen R. Wisniewski, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Name:
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David W. Morris, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas Southwestern Medical Center |
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Name:
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Diane Warden, PhD, MBA |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas Southwestern Medical Center |
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Name:
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Kathy Shores-Wilson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas Southwestern Medical Center |
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Name:
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Madhukar Trivedi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas Southwestern Medical Center |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Depression
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Secondary ID(s)
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DSIR AT
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N01 MH90003-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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