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 : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Major Depressive Disorder||Drug: Aripiprazole Device: Repetitive transcranial magnetic stimulation (rTMS) Drug: Venlafaxine XR||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||639 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Augmentation Versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With Treatment Resistant Depression (ASCERTAIN-TRD)|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Aripiprazole Augmentation
Patients randomized to this treatment arm will be instructed to continue all permitted psychotropics at their current dose throughout the 8-week trial and initiate adjunctive aripiprazole. The starting dose will be 5mg daily. The dose may be reduced to as low as 2mg for tolerability issues (this will be the lowest dose permitted for continuation in the trial). The dose may be adjusted in 2 or 5mg increments. The minimum time per increment will be 7 days. The maximum dose will be set at 15mg daily. For patients who are not on potent cytochrome 2D6 inhibitors (such as paroxetine, fluoxetine, duloxetine) or on potent cytochrome 3A4 inhibitors (such as fluvoxamine and nefazodone) and who are able to tolerate 15mg daily, the maximum dose can be raised to 20mg daily for efficacy.
Oral adjunctive therapy with aripiprazole, dose adjusted for effectiveness and tolerability.
Other Name: Abilify
Experimental: rTMS Augmentation
Patients randomized to this treatment arm will be instructed to continue all permitted psychotropics at their current dose throughout the 8-week trial. We will use clinical TMS stimulators with focal figure-of-eight coils. We will start by measuring the patient´s motor threshold (MT), which is a measure of cortical excitability used to standardize the intensity of stimulation across subjects.
Device: Repetitive transcranial magnetic stimulation (rTMS)
Adjunctive therapy with transcranial magnetic stimulation, dose adjusted for effectiveness and tolerability.
Experimental: Switching To Venlafaxine XR
Patients randomized to this treatment arm will be instructed to continue all permitted psychotropics throughout the 8-week trial, except for their antidepressant(s). They will be instructed to discontinue all antidepressants and initiate venlafaxine that day, as direct switch to serotonergic antidepressants is well tolerated and avoids loss of precious therapeutic time (Montgomery et al., 2014), including to switching to venlafaxine in STAR*D (Rush et al., 2006b). For patients who do not prefer a direct switch, or when clinically indicated otherwise in the opinion of the site investigator, a gradual tapering during the screening period will be permitted as long as a direct switch to venlafaxine is made on the baseline visit from the final antidepressant dose. The starting dose of venlafaxine will be 75mg daily. The dose may be reduced to as low as 37.5mg for tolerability issues (this will be the lowest dose permitted for continuation in the trial).
Drug: Venlafaxine XR
Oral switch therapy with venlafaxine, dose adjusted for effectiveness and tolerability.
Other Name: Effexor XR
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]Assessment of depression severity.
- Quality of Life, Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: 8 weeks ]Assessment of quality of life
- Massachusetts General Hospital Cognitive and Physical Symptoms Questionnaire (MGH CPFQ) [ Time Frame: 8 weeks ]Assessment of cognitive symptoms
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): NCT02977299
|Contact: Max Martinsonemail@example.com|
|Contact: George I Papakostas, MDfirstname.lastname@example.org|
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