VA Augmentation and Switching Treatments for Improving Depression Outcomes

PHASE3CompletedINTERVENTIONAL
Enrollment

1,522

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

June 30, 2016

Conditions
Major Depressive Disorder
Interventions
DRUG

Switching: Bupropion-SR

Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

DRUG

Augmenting: Antidepressant + Bupropion-SR

"Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.~And~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."

DRUG

Augmenting: Antidepressant + Aripiprazole

"Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.~And~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."

Trial Locations (35)

15240

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh

19104

Philadelphia VA Medical Center, Philadelphia, PA, Philadelphia

20422

Washington DC VA Medical Center, Washington, DC, Washington D.C.

21201

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore

24153

Salem VA Medical Center, Salem, VA, Salem

26301

Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV, Clarksburg

28144

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury

28805

Asheville VA Medical Center, Asheville, NC, Asheville

30033

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

33125

Miami VA Healthcare System, Miami, FL, Miami

33612

James A. Haley Veterans' Hospital, Tampa, FL, Tampa

35404

Tuscaloosa VA Medical Center, Tuscaloosa, AL, Tuscaloosa

38104

Memphis VA Medical Center, Memphis, TN, Memphis

44106

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland

45220

Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati

53705

William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison

55417

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

63106

St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis

64128

Kansas City VA Medical Center, Kansas City, MO, Kansas City

76504

Central Texas Veterans Health Care System, Temple, TX, Temple

80220

VA Eastern Colorado Health Care System, Denver, CO, Denver

85012

Phoenix VA Health Care System, Phoenix, AZ, Phoenix

85723

Southern Arizona VA Health Care System, Tucson, Tucson

90822

VA Long Beach Healthcare System, Long Beach, CA, Long Beach

92161

VA San Diego Healthcare System, San Diego, CA, San Diego

92357

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda

94121

San Francisco VA Medical Center, San Francisco, CA, San Francisco

98493

VA Puget Sound Health Care System American Lake Division, Tacoma, WA, Tacoma

94304-1290

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto

06516

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven

60141-5000

Edward Hines Jr. VA Hospital, Hines, IL, Hines

46202-2884

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis

68105-1873

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha

87108-5153

New Mexico VA Health Care System, Albuquerque, NM, Albuquerque

53295-1000

Clement J. Zablocki VA Medical Center, Milwaukee, WI, Milwaukee

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT01421342 - VA Augmentation and Switching Treatments for Improving Depression Outcomes | Biotech Hunter | Biotech Hunter