Methamphetamine-induced PsychosisPhase 4MAPNCT01939093
Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
A Phase 4 study testing Diazepam, Vitamin B1-6-12 and Stugeron in people with Methamphetamine-induced Psychosis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine-induced Psychosis
- What is being tested?
- Diazepam, Vitamin B1-6-12 and Stugeron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2010to Sep 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a psychotic episode with current use of methamphetamine
- Positive urine toxicology test for methamphetamine on the first day of hospitalization
Who cannot join
- Using other illegal substances
- Having a history of primary psychotic disorders or using antipsychotic agents
- Having a chronic medical disease, e.g. essential hypertension, diabetes, epilepsy, stroke
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thanyarak Institute on Drug Abuse
Pathum Thani, Changwat Pathum Thani
About this study
Official title: Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis
The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.
Read the detailed description
Eighty individuals with MAP will be randomly assigned into two treatment groups, i.e. treatment with quetiapine and haloperidol. The quetiapine group will receive quetiapine at least 100 mg per day and the haloperidol group will receive haloperidol at least 2 mg per day orally once a day for four weeks. The doses will be increased every 5 days until no psychotic symptom is observed from the Positive and Negative Syndrome Scale. Common antipsychotic adverse events will be checked and documented daily.
- Conditions
- Methamphetamine-induced Psychosis
- Being tested
- Diazepam, Vitamin B1-6-12, Stugeron
- Keywords
- Quetiapine, Haloperidol, Methamphetamine, Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
If subjects had aggressive or violent symptoms and immediate symptom control was needed, 10 mg of diazepam (intravenous injection) every 4 hours is allowed for symptom control.
Vitamin B1-6-12Dietary supplement
All subjects will be given the Institute's medication regimen, including vitamin B1-6-12 1 tablet three times a day after meals during the whole study period.
StugeronDrug
All subjects will be given the Institute's medication regimen, including stugeron 1 tablet three times a day after meals during the whole study period.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | Quetiapine 100 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed. Receives: Drug: Diazepam; Dietary Supplement: Vitamin B1-6-12; Drug: Stugeron |
| Haloperidol | Active comparator | Haloperidol 2 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed. Receives: Drug: Diazepam; Dietary Supplement: Vitamin B1-6-12; Drug: Stugeron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale
Measured: Every day in Week 1.
Positive and Negative Syndrome Scale
Measured: Every two days in Week 2 and 3.
Secondary outcomes (1)
Antipsychotic Adverse Event Form
Measured: Every day for three weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startMar 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine-induced PsychosisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Thanyarak Institute, National Research Council of Thailand
- Responsible party
- Principal investigator, Rasmon Kalayasiri, Chulalongkorn University
- Investigators
- Viroj Verachai, M.D., Principal investigator, Thanyarak Institute on Drug Abuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939093
- Sponsor's protocol ID
- NRCT-53069
- Acronym
- MAP
- Status last verified
- Sep 2013
- First submitted
- 2 Sep 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis
- ClinicalTrials.gov ID
- NCT01939093
- Acronym / sponsor ID
- MAP / NRCT-53069
- Conditions
- Methamphetamine-induced Psychosis
- Keywords
- Quetiapine, Haloperidol, Methamphetamine, Psychosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Thanyarak Institute, National Research Council of Thailand
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Sep 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.
The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.
Detailed description
Eighty individuals with MAP will be randomly assigned into two treatment groups, i.e. treatment with quetiapine and haloperidol. The quetiapine group will receive quetiapine at least 100 mg per day and the haloperidol group will receive haloperidol at least 2 mg per day orally once a day for four weeks. The doses will be increased every 5 days until no psychotic symptom is observed from the Positive and Negative Syndrome Scale. Common antipsychotic adverse events will be checked and documented daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: Diazepam, Dietary Supplement: Vitamin B1-6-12, Drug: StugeronQuetiapine 100 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed. |
| Haloperidol | Active comparator | Drug: Diazepam, Dietary Supplement: Vitamin B1-6-12, Drug: StugeronHaloperidol 2 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having a psychotic episode with current use of methamphetamine
- Positive urine toxicology test for methamphetamine on the first day of hospitalization
Key exclusion criteria (3 listed)
- Using other illegal substances
- Having a history of primary psychotic disorders or using antipsychotic agents
- Having a chronic medical disease, e.g. essential hypertension, diabetes, epilepsy, stroke
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 |
|---|---|---|
| DiazepamIf subjects had aggressive or violent symptoms and immediate symptom control was needed, 10 mg of diazepam (intravenous injection) every 4 hours is allowed for symptom control. | Drug | Haloperidol, Quetiapine |
| Vitamin B1-6-12All subjects will be given the Institute's medication regimen, including vitamin B1-6-12 1 tablet three times a day after meals during the whole study period. | Dietary supplement | Haloperidol, Quetiapine |
| StugeronAll subjects will be given the Institute's medication regimen, including stugeron 1 tablet three times a day after meals during the whole study period. | Drug | Haloperidol, Quetiapine |
Primary outcome
Positive and Negative Syndrome Scale
Time frame: Every day in Week 1.
Positive and Negative Syndrome Scale
Time frame: Every two days in Week 2 and 3.
1 secondary outcome
Antipsychotic Adverse Event Form
Time frame: Every day for three weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
Related trials for Methamphetamine-induced Psychosis
RecruitingObservational study
Psychiatric Symptom Predictors in Methamphetamine-Induced Psychosis
Methamphetamine Induced Psychosis
RecruitingObservational study
ECG Findings in Methamphetamine Use
Methamphetamine Use Disorder, Methamphetamine Induced Psychosis
RecruitingObservational study
Psychiatric Symptom Characteristics in Methamphetamine-Induced Psychosis With and Without Lifetime Cannabis Use
Methamphetamine Induced Psychosis, Cannabis Use
Active, not recruiting
Effectiveness of Stress Management Training Program For Expressed Emotions in Caregivers of Drug Induced Psychosis Patients Specially Methamphetamine
Caregiver Burden in Methamphetamine Use Disorder, Expressed Emotions in Caregivers
Not yet recruitingObservational study
This Hospital-based Observational Study Employed a Study Will be Conducted in Sohag University Hospital Clinics Aiming to Ensure Cases Presented With Psychosis in Two Phases to Differentiate Into Two Groups a Case of Schizophrenia or a Case of Methamphetamine Induced Psychosis.
Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis, SCHIZOPHRENIA
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.
Viroj Verachai, M.D. principal investigator
Thanyarak Institute on Drug Abuse
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 Diazepam, Vitamin B1-6-12 and Stugeron in people with Methamphetamine-induced Psychosis, run by Chulalongkorn University at 1 site in Thailand.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 Sep 2013. 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 Thailand. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive and Negative Syndrome Scale (time frame: Every day in Week 1.). The study lists 2 primary outcomes in all. 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 11 Sep 2013.