Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression
NCT ID: NCT00532103
Last Updated: 2008-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2007-07-31
2008-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Responsible Party
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The University of Texas Southwestern Medical Center
Principal Investigators
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Madhukar Trivedi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Stephen R. Wisniewski, PhD
Role: STUDY_DIRECTOR
University of Pittsburgh
Diane Warden, PhD, MBA
Role: STUDY_DIRECTOR
University of Texas Southwestern Medical Center
Kathy Shores-Wilson, PhD
Role: STUDY_DIRECTOR
University of Texas Southwestern Medical Center
David W. Morris, PhD
Role: STUDY_DIRECTOR
University of Texas Southwestern Medical Center
Locations
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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
Countries
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References
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Jha MK, Minhajuddin A, South C, Rush AJ, Trivedi MH. Irritability and Its Clinical Utility in Major Depressive Disorder: Prediction of Individual-Level Acute-Phase Outcomes Using Early Changes in Irritability and Depression Severity. Am J Psychiatry. 2019 May 1;176(5):358-366. doi: 10.1176/appi.ajp.2018.18030355. Epub 2019 Mar 29.
Gollan JK, Fava M, Kurian B, Wisniewski SR, Rush AJ, Daly E, Miyahara S, Trivedi MH. What are the clinical implications of new onset or worsening anxiety during the first two weeks of SSRI treatment for depression? Depress Anxiety. 2012 Feb;29(2):94-101. doi: 10.1002/da.20917. Epub 2011 Dec 6.
Trivedi MH, Wisniewski SR, Morris DW, Fava M, Kurian BT, Gollan JK, Nierenberg AA, Warden D, Gaynes BN, Luther JF, Rush AJ. Concise Associated Symptoms Tracking scale: a brief self-report and clinician rating of symptoms associated with suicidality. J Clin Psychiatry. 2011 Jun;72(6):765-74. doi: 10.4088/JCP.11m06840.
Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837.
Warden D, Trivedi MH, Wisniewski SR, Kurian B, Zisook S, Kornstein SG, Friedman ES, Miyahara S, Leuchter AF, Fava M, Rush AJ. Early adverse events and attrition in selective serotonin reuptake inhibitor treatment: a suicide assessment methodology study report. J Clin Psychopharmacol. 2010 Jun;30(3):259-66. doi: 10.1097/JCP.0b013e3181dbfd04.
Other Identifiers
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DSIR AT
Identifier Type: -
Identifier Source: secondary_id
N01 MH90003-01
Identifier Type: -
Identifier Source: org_study_id