Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression

Completed

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00532103

Run by

National Institute of Mental Health (NIMH)

People needed

300

Starts

2007-07-01

Expected to finish

2008-02-01

Last updated by the study team

2008-09-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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