Trial record 8 of 483 for:    Open Studies | antidepressants

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01421342
First received: August 5, 2011
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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-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 (SSRI or 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 Intervention Phase
Major Depressive Disorder
Drug: Augmenting: Antidepressant + Aripiprazole
Drug: Augmenting: Antidepressant + Bupropion-SR
Drug: Switching: Bupropion-SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #576 - VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Remission of symptoms of major depressive disorder [ Time Frame: During acute phase (12 weeks) ] [ Designated as safety issue: No ]
    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:
  • Relapse in symptoms of major depression [ Time Frame: During acute phase (up to 12 weeks) and continuation phase (from 12 weeks up to 36 weeks) ] [ Designated as safety issue: No ]
    Relapse in symptoms of major depression defined as a QIDS-C16 => 11 after remission.

  • Response in symptoms of major depression [ Time Frame: During acute phase (up to 12 weeks) and continuation phase (from 12 weeks up to 36 weeks) ] [ Designated as safety issue: No ]
    Response in symptoms of major depression defined as a reduction in QIDS-C16 of 50% or greater.

  • Onset or cessation of akathisia [ Time Frame: During acute phase (up to 12 weeks) and continuation phase (from 12 weeks up to 36 weeks) ] [ Designated as safety issue: No ]
    Onset or cessation of akathisia, or change in symptom proclivity to as measured by the Barnes Akathisia Scale (Barnes 1989).

  • Onset or cessation of anxiety [ Time Frame: During acute phase (up to 12 weeks) and continuation phase (from 12 weeks up to 36 weeks) ] [ Designated as safety issue: No ]
    Anxiety will be assessed by Beck Anxiety Inventory (BAI) (Beck, Epstein et al. 1988).

  • Onset or cessation of suicide ideation [ Time Frame: During acute phase (up to 12 weeks) and continuation phase (from 12 weeks up to 36 weeks) ] [ Designated as safety issue: Yes ]
    Suicide ideation and behaviors will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).

  • Change in Clinical Global Impression Scale [ Time Frame: During acute phase (up to 12 weeks) and continuation phase (from 12 weeks up to 36 weeks) ] [ Designated as safety issue: No ]
    Clinical assessment of a participant's level of depression and treatment response assessed by the Clinical Global Impression - Severity (CGI -S) Scale, a 7-point clinician rating scale of the severity of depression and the Clinical Global Impression - Improvement (CGI -I) Scale, a 7-point clinician rating scale of improvement from baseline in severity of depression (Guy 1976).

  • Emergence of adverse experiences [ Time Frame: During acute phase (up to 12 weeks) and continuation phase (from 12 weeks up to 36 weeks) ] [ Designated as safety issue: Yes ]
    Side effects, tolerability and discontinuation of medications will be assessed by the patient-rated Frequency and Intensity of Side Effects Rating/Global Rating of Side-Effect Burden (FIBSER) (Wisniewski, Rush et al. 2006) and by recording the occurrence of commonly reported side effects of antidepressant and atypical -psychotic medications, and the occurrence of serious or unexpected adverse experiences.

  • Cost and Cost-Effectiveness [ Time Frame: During acute phase (up to 12 weeks) and continuation phase (from 12 weeks up to 36 weeks) ] [ Designated as safety issue: No ]
    Costs will be assessed by costs of care and health care utilization, and cost-effectiveness assessed by the ratio of costs to quality-adjusted life years.


Estimated Enrollment: 1518
Study Start Date: December 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
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.

Active Comparator: Arm 2
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: Arm 3
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421342

Contacts
Contact: Somaia Mohamed, PhD (203) 932-5711 ext 4015 Somaia.Mohamed@va.gov
Contact: Mary LeGwin, BS Mary.LeGwin@va.gov

  Show 35 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Somaia Mohamed, PhD VA Connecticut Health Care System (West Haven)
Study Chair: Sidney Zisook, MD VA San Diego Healthcare System, San Diego, CA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01421342     History of Changes
Other Study ID Numbers: 576
Study First Received: August 5, 2011
Last Updated: May 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Antidepressant
Mood Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Bupropion
Aripiprazole
Remission
Relapse
Cost-Effectiveness
Atypical Antipsychotic
Augmentation
Veterans
Mental Health

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Second-Generation
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Aripiprazole
Bupropion
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014