MBRP + Vortioxetine VS MBRP on Preventing Relapse in Chronic MA Users

• Status: Unknown status
• Trial end date: 2021-04-30
• Target enrollment: 0
• Participant gender: All

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 abstinence rates, improvement of cognition and depressive symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central South University; Sir Run Run Shaw Hospital
• Collaborators: Huazhong University of Science and Technology; Shenzhen Mental Health Center
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

1. DSM-V diagnosis of MA dependence within the last year

2. completion or scheduled completion (i.e., within 2 weeks) of inpatient or intensive outpatient treatment for MA dependence.

3. express a wish to remain abstinent from MA use

4. be age 18 to 65

5. 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

6. willingness to randomization and attendance at treatment and assessment sessions

7. be able to attend all clinic visits without interruption

8. score greater than 16 on the HAM D17 and MADRS >= 26, as well as currently not on any psychotropics for treatment of depression

Exclusion Criteria:

1. 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.

2. Serious medical comorbidity requiring medical intervention or close supervision, including pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation, gross neurological disease

3. Suicide attempt in the last 3 months

4. Pregnant or breastfeeding women

5. Prior treatment with vortioxetine or already participated in the MBRP program

6. Fail to provide informed consent