RelapsePhase 4NCT03830827
MBRP + Vortioxetine VS MBRP on Preventing Relapse in Chronic MA Users
A Phase 4 study testing Vortioxetine in people with Relapse and Cognitive Impairment, run by Sir Run Run Shaw Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapse, Cognitive Impairment, Depression
- What is being tested?
- Vortioxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 30 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Mindfulness-based Relapse Prevention With or Without Vortioxetine on the Prevention of Relapse in Chronic Methamphetamine Users
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.
Read the 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#/day placebo combined with MBRP intervention.
Vortioxetine (Brintellix®), a novel antidepressant for the treatment of adult with major depressive disorder, has been approved by the Chinese Food and Drug Administration in the use of China in 2018.
The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse. In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component. Group sessions include discussions of mindfulness as a means of coping with MA craving, negative affect and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice and implement practice into high-risk situations and in daily life, as well as homework assignments.
Participants from both groups will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.
- Conditions
- Relapse, Cognitive Impairment, Depression
- Being tested
- Vortioxetine
- Medical subject headings
- Recurrence, Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Mindfulness-based relapse prevention
8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| MBRP+vortioxetine intervention | Experimental | Participants who allocate to the experimental group will receive 8-week 10-20mg/day vortioxetine combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse.
10-20mg/day vortioxetine will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving. Receives: Drug: Vortioxetine |
| MBRP intervention | Experimental | Participants who allocate to the control group will receive 8-week 1-2#/day placebo combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse.
1-2#/day placebo will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving. Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Timeline Followback (TLFB) for MA relapse rates
The primary objective is Methamphetamine (MA) relapse rates will be assessed by the Timeline Follow Back (TFB) at weeks 1, 2, 3, 4, 5, 6, 7, 8, and 24. TLFB is a technique for assessing self-reported alcohol or drug consumption that can be used as a clinical and research tool to obtain a variety of quantitative estimates of MA use. This outcome measure integrates data from self-reported supplied in the Time Line Follow Back (a self-reported summary of all substance use over the previous week) with biological verification.
Measured: 24 weeks
Secondary outcomes (2)
Depressive symptoms will be assessed by Montgomery and Asberg Depression Rating Scale (MADRS, Chinese version)
The efficacy of intervention for depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 2) to Week 24 (Visit 10). MADRS is a 10-item rating scale designed to measure overall severity of the symptoms in depressive and to be sensitive to treatment effects. Symptoms are rated on a 7-point Likert scale from 0 (no symptom) to 6 (severe symptom) with an overall score range from 0 to 60. Participants were considered responsive to vortioxetine if their MADRS score decreased by 50% or more from baseline to the end of treatment，and to be in remission if their final MADRS score is less than 10. A higher score indicates a more severe symptom, and a lower score from the baseline indicates an improvement in symptoms.
Measured: 24 weeks
Cognition function will be assessed by THINC-it® cognition screening tool
THINC-it® is a sensitive cognitive screening tool for measuring the change of cognitive function and determining whether cognitive function is impaired. It required approximately 10 to 15 minutes for administration. It includes variants of the Choice Reaction Time Identification Task (IDN), One-Back Test, Digit Symbol Substitution Test, Trail Making Test-Part B, and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Sep 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RelapseStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Mental Health Center, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Yanhui Liao, Sir Run Run Shaw Hospital
- Investigators
- Yanhui Liao, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830827
- Sponsor's protocol ID
- S2018008
- Status last verified
- Nov 2019
- First submitted
- 14 Jan 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mindfulness-based Relapse Prevention With or Without Vortioxetine on the Prevention of Relapse in Chronic Methamphetamine Users
- ClinicalTrials.gov ID
- NCT03830827
- Acronym / sponsor ID
- S2018008
- Conditions
- Relapse, Cognitive Impairment, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Mental Health Center, Huazhong University of Science and Technology
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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#/day placebo combined with MBRP intervention.
Vortioxetine (Brintellix®), a novel antidepressant for the treatment of adult with major depressive disorder, has been approved by the Chinese Food and Drug Administration in the use of China in 2018.
The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse. In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component. Group sessions include discussions of mindfulness as a means of coping with MA craving, negative affect and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice and implement practice into high-risk situations and in daily life, as well as homework assignments.
Participants from both groups will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBRP+vortioxetine intervention | Experimental | Drug: VortioxetineParticipants who allocate to the experimental group will receive 8-week 10-20mg/day vortioxetine combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse. 10-20mg/day vortioxetine will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving. |
| MBRP intervention | Experimental | Drug: VortioxetineParticipants who allocate to the control group will receive 8-week 1-2#/day placebo combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse. 1-2#/day placebo will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineAlso: Mindfulness-based relapse prevention8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks | Drug | MBRP intervention, MBRP+vortioxetine intervention |
Primary outcome
The Timeline Followback (TLFB) for MA relapse rates
Time frame: 24 weeks
The primary objective is Methamphetamine (MA) relapse rates will be assessed by the Timeline Follow Back (TFB) at weeks 1, 2, 3, 4, 5, 6, 7, 8, and 24. TLFB is a technique for assessing self-reported alcohol or drug consumption that can be used as a clinical and research tool to obtain a variety of quantitative estimates of MA use. This outcome measure integrates data from self-reported supplied in the Time Line Follow Back (a self-reported summary of all substance use over the previous week) with biological verification.
2 secondary outcomes
Depressive symptoms will be assessed by Montgomery and Asberg Depression Rating Scale (MADRS, Chinese version)
Time frame: 24 weeks
Cognition function will be assessed by THINC-it® cognition screening tool
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanhui Liao, MD principal investigator
Sir Run Run Shaw Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine in people with Relapse and Cognitive Impairment, run by Sir Run Run Shaw Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Wu, MD (+8618865477115, zhenzhenjw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Timeline Followback (TLFB) for MA relapse rates (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.