Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD (ASCERTAINTRD)
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ClinicalTrials.gov Identifier: NCT02977299 |
Recruitment Status :
Recruiting
First Posted : November 30, 2016
Last Update Posted : September 2, 2020
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Sponsor:
Massachusetts General Hospital
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
George I. Papakostas, Massachusetts General Hospital
Tracking Information | |||||||||
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First Submitted Date ICMJE | November 28, 2016 | ||||||||
First Posted Date ICMJE | November 30, 2016 | ||||||||
Last Update Posted Date | September 2, 2020 | ||||||||
Actual Study Start Date ICMJE | May 1, 2017 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] Assessment of depression severity.
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Original Primary Outcome Measures ICMJE |
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
Quality of Life, Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: 8 weeks ] Assessment of quality of life
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Original Secondary Outcome Measures ICMJE |
Quality of Life, Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: 8 weeks ] | ||||||||
Current Other Pre-specified Outcome Measures |
Massachusetts General Hospital Cognitive and Physical Symptoms Questionnaire (MGH CPFQ) [ Time Frame: 8 weeks ] Assessment of cognitive symptoms
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Original Other Pre-specified Outcome Measures |
Massachusetts General Hospital Cognitive and Physical Symptoms Questionnaire (MGH CPFQ) [ Time Frame: 8 weeks ] | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD | ||||||||
Official Title ICMJE | Augmentation Versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With Treatment Resistant Depression (ASCERTAIN-TRD) | ||||||||
Brief Summary | This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 4 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Treatment Resistant Major Depressive Disorder | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Franck LS, Shellhaas RA, Lemmon M, Sturza J, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Thomas C, Rogers EE, McCulloch CE, Grant K, Grossbauer L, Pawlowski K, Glass HC; Neonatal Seizure Registry study group. Associations between Infant and Parent Characteristics and Measures of Family Well-Being in Neonates with Seizures: A Cohort Study. J Pediatr. 2020 Jun;221:64-71.e4. doi: 10.1016/j.jpeds.2020.02.024. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
639 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 2022 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, Italy, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02977299 | ||||||||
Other Study ID Numbers ICMJE | 2015P002430 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | George I. Papakostas, Massachusetts General Hospital | ||||||||
Study Sponsor ICMJE | Massachusetts General Hospital | ||||||||
Collaborators ICMJE | Patient-Centered Outcomes Research Institute | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Massachusetts General Hospital | ||||||||
Verification Date | August 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |