Status:
UNKNOWN
MBRP + Vortioxetine VS MBRP on Preventing Relapse in Chronic MA Users
Lead Sponsor:
Sir Run Run Shaw Hospital
Collaborating Sponsors:
Shenzhen Mental Health Center
Huazhong University of Science and Technology
Conditions:
Relapse
Cognitive Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This multicenter, double-blind, Randomized, parallel-group study in subjects with methamphetamine dependence was to assess the efficacy of MBRP combined with vortioxetine and MBRP alone on 24-week abs...
Detailed Description
Participants who allocate to the experimental group will receive 8-week 10-20mg/day vortioxetine combined with MBRP intervention. Participants who allocate to the control group will receive 8-week 1-2...
Eligibility Criteria
Inclusion
- DSM-V diagnosis of MA dependence within the last year
- completion or scheduled completion (i.e., within 2 weeks) of inpatient or intensive outpatient treatment for MA dependence.
- express a wish to remain abstinent from MA use
- be age 18 to 65
- be fluent in speaking Mandarin and literate in Chinese and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of mindfulness techniques
- willingness to randomization and attendance at treatment and assessment sessions
- be able to attend all clinic visits without interruption
- score greater than 16 on the HAM D17 and MADRS \>= 26, as well as currently not on any psychotropics for treatment of depression
Exclusion
- Any current Axis I DSM-V psychiatric disorder other than MA or nicotine dependence that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality, mental retardation et al.
- Serious medical comorbidity requiring medical intervention or close supervision, including pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation, gross neurological disease
- Suicide attempt in the last 3 months
- Pregnant or breastfeeding women
- Prior treatment with vortioxetine or already participated in the MBRP program
- Fail to provide informed consent
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03830827
Start Date
September 1 2020
End Date
April 30 2021
Last Update
November 29 2019
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