Methamphetamine DependencePhase 4NCT01813643
A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis
A Phase 4 study testing Risperidone and Aripiprazole in people with Methamphetamine Dependence, run by Wei Hao at 1 site in China.
Trial summary
Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Risperidone and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Aug 2014
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
- Must sign a Information consent form.
- Required to provide detailed address and phone number
Who cannot join
- Serious organic disease.
- Suicide ideation or hurt others.
- Taking antipsychotic within two weeks before.
- drug allergy to Risperidone or Aripiprazole.
- pregnancy and breastfeeding women.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central University
Changsha, Hunan, 410011
About this study
Official title: A Multiple-Center, Randomized, Double-Blind Study of Comparison of Risperidone and Aripiprazole for Treatment
Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both risperidone and aripiprazole are second generation antipsychotics，but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole for patients with MAP.
Read the detailed description
Methods:A Multiple-Center, Randomized, Double-Blind.
- Conditions
- Methamphetamine Dependence
- Being tested
- Risperidone, Aripiprazole
- Keywords
- Methamphetamine-Associated Psychosis, Aripiprazole, Risperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperdal H20070057
Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
AripiprazoleDrug
Also called Aopai H20041507
Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Experimental | Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks. Receives: Drug: Aripiprazole |
| Risperidone | Active comparator | Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of psychosis
Positive and Negative Syndrome Scale
Measured: up to 4 weeks. participants will be followed for the duration of hospital stay
Secondary outcomes (2)
adverse drug reaction
Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale
Measured: up to 4 weeks. participants will be followed for the duration of hospital
Clinical general status
Clinical general rating scale
Measured: up to 4 weeks. participants will be followed for the duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionAug 2014
Why it stopped: Effects of aripiprazole was not obvious and showed adverse reaction obviously
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Hao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Hao, Central South University
- Investigators
- Wei Hao, MD., Ph.D., Study director, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813643
- Sponsor's protocol ID
- 100000-068941
- Status last verified
- Feb 2015
- First submitted
- 19 Aug 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Center, Randomized, Double-Blind Study of Comparison of Risperidone and Aripiprazole for Treatment
- ClinicalTrials.gov ID
- NCT01813643
- Acronym / sponsor ID
- 100000-068941
- Conditions
- Methamphetamine Dependence
- Keywords
- Methamphetamine-Associated Psychosis, Aripiprazole, Risperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Effects of aripiprazole was not obvious and showed adverse reaction obviously
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wei HaoUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Mar 2013 (estimated)
- 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.
Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both risperidone and aripiprazole are second generation antipsychotics，but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole for patients with MAP.
Detailed description
Methods:A Multiple-Center, Randomized, Double-Blind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: AripiprazoleAripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks. |
| Risperidone | Active comparator | Drug: RisperidoneRisperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
- Must sign a Information consent form.
- Required to provide detailed address and phone number
Key exclusion criteria (5 listed)
- Serious organic disease.
- Suicide ideation or hurt others.
- Taking antipsychotic within two weeks before.
- drug allergy to Risperidone or Aripiprazole.
- pregnancy and breastfeeding women.
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 |
|---|---|---|
| RisperidoneAlso: Risperdal H20070057Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks | Drug | Risperidone |
| AripiprazoleAlso: Aopai H20041507Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks | Drug | Aripiprazole |
Primary outcome
The severity of psychosis
Time frame: up to 4 weeks. participants will be followed for the duration of hospital stay
Positive and Negative Syndrome Scale
2 secondary outcomes
adverse drug reaction
Time frame: up to 4 weeks. participants will be followed for the duration of hospital
Clinical general status
Time frame: up to 4 weeks. participants will be followed for the duration of hospital stay
Results and safety
The study was stopped early (reason given: Effects of aripiprazole was not obvious and showed adverse reaction obviously). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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.
Wei Hao, MD., Ph.D. study director
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone and Aripiprazole in people with Methamphetamine Dependence, run by Wei Hao at 1 site in China.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Effects of aripiprazole was not obvious and showed adverse reaction obviously). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of psychosis (time frame: up to 4 weeks. participants will be followed for the duration of hospital stay). 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 4 Feb 2015.