Major Depressive Disorder Clinical Trial
— VAST-DOfficial title:
CSP #576 - VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)
NCT number | NCT01421342 |
Other study ID # | 576 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | December 2012 |
Est. completion date | June 2016 |
Verified date | April 2018 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall purpose is to determine research based 'next-steps' for outpatients with major depressive disorder who have not had satisfactory outcomes to standard 'first-step' treatments. The primary objective is to compare the acute (up to 12 weeks) treatment effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-slow release (SR) vs. switching treatment to bupropion-SR monotherapy on symptom remission in Veterans with Major Depressive Disorder (MDD) who have not achieved optimal response after an adequate trial on antidepressant (a selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI] or mirtazapine) monotherapy. The secondary objectives are to compare the acute (up to 12 weeks) and long term (up to 36 weeks) efficacy, safety, effects on functioning, suicidality, quality of life, anxiety and other associated symptoms, costs and cost-effectiveness of each of the three treatments.
Status | Completed |
Enrollment | 1522 |
Est. completion date | June 2016 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - DSM-IV diagnosis of single or recurrent, non-psychotic, major depressive disorder - Currently taking a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) or mirtazapine for major depressive disorder - Need for "next-step" treatment based on documented suboptimal outcome from current antidepressant treatment for major depressive episode (at least 6 weeks treatment with a QIDS-C16 >= 16 or at least 8 weeks with a QIDS-C16 >= 11; and at least 3 weeks at a stable "optimal" dose - Age: 18 years of age or older Exclusion Criteria: - Prior inadequate response after an adequate treatment trial or clear cut intolerance to either of the study medications (aripiprazole or bupropion) - Current treatment with bupropion, aripiprazole or any other antipsychotic agent - Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified - Current diagnosis of Dementia - Current diagnosis of an eating disorder or a seizure disorder - High suicide risk currently requiring acute intervention (other than outpatient treatment of depression) - Unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care - Requiring immediate hospitalization for psychiatric disorders - Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria) - Taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect - Concurrent or recent participation (within the last 30 days) in another conflicting clinical trial with a mental health, investigational drug, or medical device intervention - Female - pregnant or lactating or planning to become pregnant - Patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization - Patient was not referred to the study |
Country | Name | City | State |
---|---|---|---|
United States | New Mexico VA Health Care System, Albuquerque, NM | Albuquerque | New Mexico |
United States | Asheville VA Medical Center, Asheville, NC | Asheville | North Carolina |
United States | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland |
United States | Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio |
United States | Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV | Clarksburg | West Virginia |
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
United States | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia |
United States | VA Eastern Colorado Health Care System, Denver, CO | Denver | Colorado |
United States | Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois |
United States | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana |
United States | Kansas City VA Medical Center, Kansas City, MO | Kansas City | Missouri |
United States | VA Loma Linda Healthcare System, Loma Linda, CA | Loma Linda | California |
United States | VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California |
United States | William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin |
United States | Memphis VA Medical Center, Memphis, TN | Memphis | Tennessee |
United States | Miami VA Healthcare System, Miami, FL | Miami | Florida |
United States | Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin |
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
United States | Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE | Omaha | Nebraska |
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
United States | Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania |
United States | Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
United States | St. Louis VA Medical Center John Cochran Division, St. Louis, MO | Saint Louis | Missouri |
United States | Salem VA Medical Center, Salem, VA | Salem | Virginia |
United States | Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC | Salisbury | North Carolina |
United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
United States | San Francisco VA Medical Center, San Francisco, CA | San Francisco | California |
United States | VA Puget Sound Health Care System American Lake Division, Tacoma, WA | Tacoma | Washington |
United States | James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida |
United States | Central Texas Veterans Health Care System, Temple, TX | Temple | Texas |
United States | Southern Arizona VA Health Care System, Tucson | Tucson | Arizona |
United States | Tuscaloosa VA Medical Center, Tuscaloosa, AL | Tuscaloosa | Alabama |
United States | Washington DC VA Medical Center, Washington, DC | Washington | District of Columbia |
United States | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Mohamed S, Johnson GR, Chen P, Hicks PB, Davis LL, Yoon J, Gleason TC, Vertrees JE, Weingart K, Tal I, Scrymgeour A, Lawrence DD, Planeta B, Thase ME, Huang GD, Zisook S; and the VAST-D Investigators, Rao SD, Pilkinton PD, Wilcox JA, Iranmanesh A, Sapra M — View Citation
Mohamed S, Johnson GR, Vertrees JE, Guarino PD, Weingart K, Young IT, Yoon J, Gleason TC, Kirkwood KA, Kilbourne AM, Gerrity M, Marder S, Biswas K, Hicks P, Davis LL, Chen P, Kelada A, Huang GD, Lawrence DD, LeGwin M, Zisook S. The VA augmentation and switching treatments for improving depression outcomes (VAST-D) study: Rationale and design considerations. Psychiatry Res. 2015 Oct 30;229(3):760-70. doi: 10.1016/j.psychres.2015.08.005. Epub 2015 Aug 6. — View Citation
Zisook S, Tal I, Weingart K, Hicks P, Davis LL, Chen P, Yoon J, Johnson GR, Vertrees JE, Rao S, Pilkinton PD, Wilcox JA, Sapra M, Iranmanesh A, Huang GD, Mohamed S. Characteristics of U.S. Veteran Patients with Major Depressive Disorder who require "next- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Protocol Remission of Symptoms of Major Depressive Disorder | Remission of symptoms of major depression during the acute treatment phase (12 weeks) defined as a sustained clinician-rated Quick Inventory of Depressive Symptoms (QIDS-C16) of <= 5 for two consecutive visits. | During acute phase (12 weeks) | |
Secondary | Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase | Relapse in symptoms of major depression defined as a QIDS-C16 => 11 among those achieving remission in the acute phase. | Within 36 weeks after randomization (initiation of treatment) | |
Secondary | Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C) | Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater | During acute phase (up to 12 weeks) | |
Secondary | Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale | Clinical assessment of a participant's level of depression and treatment response assessed by the Clinical Global Impression - Improvement (CGI -I) Scale, a 7-point clinician rating scale of improvement from baseline in severity of depression (Guy 1976). A secondary outcome measure of response was defined as achieving a score of 2 (much improved) or 1 (very much improved). | During acute phase (up to 12 weeks) |
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