Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression

NCT00532103 | Completed DMC

• 3 other identifiers: N01 MH90003-01DSIR ATN01MH90003
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Depression

Keywords

Suicidal Ideation; Major Depressive Disorder; Suicide Risk; Antidepressant Medication

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifteen primary care and specialty care clinics across the country.

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (15)

Tuscalossa VA Mental Health Clinic

Tuscaloosa, Alabama, 35404, United States

Location

Harbor UCLA Family Health Care Center

Harbor City, California, 90710, United States

Location

UCLA Internal Medicine Clinic

Los Angeles, California, 90024, United States

Location

Veterans Affairs Medical Center/FIRM Primary Care Clinic

San Diego, California, 92161, United States

Location

Northwestern Psychiatric Outpatient Treatment Care Center

Chicago, Illinois, 60611, United States

Location

Clinical Research Institute

Wichita, Kansas, 67214, United States

Location

MGH/Northshore Medical Center (Salem Psychiatric Facility)

Salem, Massachusetts, 01970, United States

Location

General Psychiatric Ambulatory Clinic

Ann Arbor, Michigan, 48105, United States

Location

Irving Goldman Primary Care at North Shore Hospital

New York, New York, 11040, United States

Location

UNC Chapel Hill Adult Diagnostic & Treatment Clinic

Chapel Hill, North Carolina, 27599-7160, United States

Location

Laureate Psychiatric Clinic and Hospital

Tulsa, Oklahoma, 74135, United States

Location

Bellefield Clinic of WPIC

Pittsburgh, Pennsylvania, 15213, United States

Location

Vine Hill Community Clinic

Nashville, Tennessee, 37212, United States

Location

UT Southwestern Family Medicine Clinic

Dallas, Texas, 75390, United States

Location

VCU Outpatient Psychiatry Clinic

Richmond, Virginia, 23298, United States

Location

Related Publications (5)

• 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.

  PMID: 30922100 DERIVED

• 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.

  PMID: 22147631 DERIVED

• 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.

  PMID: 21733477 DERIVED

• 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.

  PMID: 21733476 DERIVED

• 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.

  PMID: 20473060 DERIVED

MeSH Terms

Conditions

Depression; Suicidal Ideation; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Madhukar Trivedi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 22, 2008

Record last verified: 2008-09

Locations

US (15)