SchizophreniaNCT02013232
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia
A study testing Aripiprazole in people with Schizophrenia, run by Beijing HuiLongGuan Hospital at 1 site in China.
Trial summary
Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Feb 2014
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;
- having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;
- being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.
Who cannot join
- any other major psychiatric disorder;
- significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, 102208
Jingxu Chen, 86-13681394260, chenjx1110@163.com
Jingxu Chen
About this study
Official title: Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study
Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with risperidone.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole
- Keywords
- Risperidone;, Aripiprazole;, Hyperprolactinemia;, dose effects
- Medical subject headings
- Schizophrenia, Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | risperidone plus placebo |
| aripiprazole 5mg | Experimental | risperidone treatment plus aripiprazole 5mg/day Receives: Drug: Aripiprazole |
| aripiprazole 10mg | Experimental | risperidone plus aripiprazole 10mg/day Receives: Drug: Aripiprazole |
| aripiprazole 20mg | Experimental | risperidone plus aripiprazole 20mg/day Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolactin level
Change from baseline in the levels of prolactin
Measured: baseline, 2 weeks, 4 weeks, 8 weeks
Secondary outcomes (1)
PANSS (positive and negative syndrome scale) score
Change from baseline in PANSS score
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing HuiLongGuan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingxu Chen, Beijing HuiLongGuan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013232
- Sponsor's protocol ID
- ARI201206
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study
- ClinicalTrials.gov ID
- NCT02013232
- Acronym / sponsor ID
- ARI201206
- Conditions
- Schizophrenia
- Keywords
- Risperidone;, Aripiprazole;, Hyperprolactinemia;, dose effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing HuiLongGuan HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 17 Dec 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.
Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with risperidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | –risperidone plus placebo |
| aripiprazole 5mg | Experimental | Drug: Aripiprazolerisperidone treatment plus aripiprazole 5mg/day |
| aripiprazole 10mg | Experimental | Drug: Aripiprazolerisperidone plus aripiprazole 10mg/day |
| aripiprazole 20mg | Experimental | Drug: Aripiprazolerisperidone plus aripiprazole 20mg/day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;
- having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;
- being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.
Key exclusion criteria (2 listed)
- any other major psychiatric disorder;
- significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation
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 |
|---|---|---|
| Aripiprazole | Drug | aripiprazole 10mg, aripiprazole 20mg, aripiprazole 5mg |
Primary outcome
Prolactin level
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks
Change from baseline in the levels of prolactin
1 secondary outcome
PANSS (positive and negative syndrome scale) score
Time frame: Baseline, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aripiprazole in people with Schizophrenia, run by Beijing HuiLongGuan Hospital 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 2 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 17 Dec 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jingxu Chen, master (86-13681394260, chenjx1110@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolactin level (time frame: baseline, 2 weeks, 4 weeks, 8 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 17 Dec 2013.