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VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01421342
Recruitment Status : Completed
First Posted : August 22, 2011
Results First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Switching: Bupropion-SR Drug: Augmenting: Antidepressant + Bupropion-SR Drug: Augmenting: Antidepressant + Aripiprazole Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CSP #576 - VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)
Study Start Date : December 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Switching: Bupropion-SR
Switching: Bupropion-SR
 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.
Active Comparator: Augmenting: Antidepressant + Bupropion-SR
Augmenting: Antidepressant + Bupropion-SR
 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.
Active Comparator: Augmenting: Antidepressant + Aripiprazole
Augmenting: Antidepressant + Aripiprazole
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Protocol Remission of Symptoms of Major Depressive Disorder [ Time Frame: During acute phase (12 weeks) ]
    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.


Secondary Outcome Measures :
  1. Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase [ Time Frame: Within 36 weeks after randomization (initiation of treatment) ]
    Relapse in symptoms of major depression defined as a QIDS-C16 => 11 among those achieving remission in the acute phase.

  2. Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C) [ Time Frame: During acute phase (up to 12 weeks) ]
    Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater

  3. Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale [ Time Frame: During acute phase (up to 12 weeks) ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421342


Locations
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Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Study Chair: Somaia Mohamed, PhD VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Study Chair: Sidney Zisook, MD VA San Diego Healthcare System, San Diego, CA
More Information
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Publications of Results:
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, Jurjus G, Michalets JP, Aslam M, Beresford T, Anderson KD, Fernando R, Ramaswamy S, Kasckow J, Westermeyer J, Yoon G, D'Souza DC, Larson G, Anderson WG, Klatt M, Fareed A, Thompson SI, Carrera CJ, Williams SS, Juergens TM, Albers LJ, Nasdahl CS, Villarreal G, Winston JL, Nogues CA, Connolly KR, Tapp A, Jones KA, Khatkhate G, Marri S, Suppes T, LaMotte J, Hurley R, Mayeda AR, Niculescu AB 3rd, Fischer BA, Loreck DJ, Rosenlicht N, Lieske S, Finkel MS, Little JT. Effect of Antidepressant Switching vs Augmentation on Remission Among Patients With Major Depressive Disorder Unresponsive to Antidepressant Treatment: The VAST-D Randomized Clinical Trial. JAMA. 2017 Jul 11;318(2):132-145. doi: 10.1001/jama.2017.8036.

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01421342    
Other Study ID Numbers: 576
First Posted: August 22, 2011    Key Record Dates
Results First Posted: May 29, 2018
Last Update Posted: May 29, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
Mood Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Bupropion
Aripiprazole
Remission
 Relapse
Cost-Effectiveness
Atypical Antipsychotic
Antidepressant
Augmentation
Veterans
Mental Health
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Aripiprazole
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists