VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)
This study is currently recruiting participants.
Verified April 2013 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: April 22, 2013
Last verified: April 2013
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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) 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 SNRI): 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 SNRI): 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 once a day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 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 3
Switching: Bupropion-SR
|
Drug: Switching: Bupropion-SR
Bupropion-SR (Dose: 150 mg - 400 mg taken once a day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Show Detailed Description 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) 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 or clear cut intolerance to the study medications (aripiprazole or bupropion)
- Current treatment with aripiprazole or any other antipsychotic agent or bupropion
- 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
- Concurrent or recent participation (within the last 30 days) in another clinical trial with an investigational drug
- Female - pregnant or lactating or planning to become pregnant
- Not able or not willing to provide informed consent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421342
Show 34 Study Locations
Contacts
| Contact: Somaia Mohamed, PhD | (203) 932-5711 ext 4015 | Somaia.Mohamed@va.gov |
| Contact: Mary LeGwin, BS | Mary.LeGwin@va.gov |
Show 34 Study LocationsSponsors and Collaborators
Investigators
| Study Chair: | Somaia Mohamed, PhD | VA Connecticut Health Care System (West Haven) |
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: | April 22, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
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:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents Bupropion Aripiprazole Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Antidepressive Agents, Second-Generation Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 18, 2013