HyperprolactinemiaPhase 4NCT00541554
Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia
A Phase 4 study testing Abilify (aripiprazole) in people with Hyperprolactinemia and Weight Gain, run by Genovate Biotechnology Co., Ltd.,.
Trial summary
This is a prospective, open-label study to evaluate the efficacy and safety in reducing antipsychotic-induced hyperprolactinemia, weight gain, and dyslipidemia by aripiprazole. Approximate 60 patients will be recruited to achieve at least 40 evaluable patients. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Hyperprolactinemia, Weight Gain, Dyslipidemia
- What is being tested?
- Abilify (aripiprazole)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2007to Feb 2009
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female in age between 12 and 65 years old.
- Clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder with DSM-IV criteria.
- Keep stable dosage of the same antipsychotic other than aripiprazole during last one month.
- Who are currently taking antipsychotic drugs and for whom an alteration in medication is clinically reasonable. This includes patients who are stable or who have symptoms that are not optimally controlled or patients experiencing tolerability problems.
- Having antipsychotic-induced symptomatic hyperprolactinemia, weight gain, increased plasma glucose or dyslipidemia judged by the investigator.
- Informed Consent was obtained from the subject and legal guardian (if necessary).
Who cannot join
- Pregnant or breast feeding women or planning a pregnancy.
- Patient has a history of hypersensitivity or allergy to investigated drug.
- Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
- Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
- Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia by Aripiprazole Add-on Therapy in the Treatment of Schizophrenia and Bipolar Disorder: An Open-Label Trial
This is a prospective, open-label study to evaluate the efficacy and safety in reducing antipsychotic-induced hyperprolactinemia, weight gain, and dyslipidemia by aripiprazole. Approximate 60 patients will be recruited to achieve at least 40 evaluable patients.
Read the detailed description
A.Screening / Baseline visit (V1; Day 0) After signing the informed consent form, patients' DSM-IV multiaxial examination, physical examination, vital sign, pregnancy test, BMI will be conducted. The demographics, medical history, and concomitant medication will be recorded. After evaluating all variables obtained, the eligible patients will be enrolled into study.Patients who fulfill the inclusion / exclusion criteria will be performed the laboratory tests, PANSS, EPS (AIMS \& BARS), menstrual function, sexual function (Arizona sexual experience scale) and prolaction. Afterwards, the treatment period will be started to add-on with first medication (7.5 or 15 mg daily by patient, which was prescribed by investigator) to current antipsychotics at this visit. Besides, drug accounting and adverse events will also be recorded at this visit. Patients are maintained on current doses of antipsychotics, and all other medicines.
B.Treatment phase (V2~V3; 2~4 Week finished; 14±3~28±3 Day finished) The vital sign, physical examination, BMI, laboratory tests (at V3), PANSS, EPS (AIMS \& BARS), menstrual function, sexual function (Arizona sexual experience scale), and prolactin will be carried out. Concomitant medication, adverse events, and drug accounting will also be recorded at this visit. Study drug could be titrated with a flexible dose from 7.5 to 30 mg QD. All dose adjustments should be made with the approval of the investigator.
C.Completion visit (V4; 8 Week Finished; 56±7 Day finished, or Early termination) The vital sign, physical examination, pregnancy test, BMI, laboratory tests, PANSS, EPS (AIMS \& BARS), menstrual function, sexual function (Arizona sexual experience scale), prolactin will be carried out. Concomitant medication, adverse events, and drug accounting will also be recorded at this visit.
- Conditions
- Hyperprolactinemia, Weight Gain, Dyslipidemia
- Being tested
- Abilify (aripiprazole)
- Medical subject headings
- Hyperprolactinemia, Weight Gain, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abilify (aripiprazole)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startOct 2007
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperprolactinemiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Chen Chih-Ken, PhD, Principal investigator, Chang Gung Memorial Hospital, Keelung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541554
- Sponsor's protocol ID
- 31-06-P05
- Status last verified
- Oct 2007
- First submitted
- 8 Oct 2007
- Last updated
- 10 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen CK, Huang YS, Ree SC, Hsiao CC. Differential add-on effects of aripiprazole in resolving hyperprolactinemia induced by risperidone in comparison to benzamide antipsychotics. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Dec 1;34(8):1495-9. doi: 10.1016/j.pnpbp.2010.08.012. Epub 2010 Aug 20.
PubMed 20732372
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia by Aripiprazole Add-on Therapy in the Treatment of Schizophrenia and Bipolar Disorder: An Open-Label Trial
- ClinicalTrials.gov ID
- NCT00541554
- Acronym / sponsor ID
- 31-06-P05
- Conditions
- Hyperprolactinemia, Weight Gain, Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Study completion
- Feb 2009 (estimated)
- First posted
- 10 Oct 2007 (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.
This is a prospective, open-label study to evaluate the efficacy and safety in reducing antipsychotic-induced hyperprolactinemia, weight gain, and dyslipidemia by aripiprazole. Approximate 60 patients will be recruited to achieve at least 40 evaluable patients.
Detailed description
A.Screening / Baseline visit (V1; Day 0) After signing the informed consent form, patients' DSM-IV multiaxial examination, physical examination, vital sign, pregnancy test, BMI will be conducted. The demographics, medical history, and concomitant medication will be recorded. After evaluating all variables obtained, the eligible patients will be enrolled into study.Patients who fulfill the inclusion / exclusion criteria will be performed the laboratory tests, PANSS, EPS (AIMS \& BARS), menstrual function, sexual function (Arizona sexual experience scale) and prolaction. Afterwards, the treatment period will be started to add-on with first medication (7.5 or 15 mg daily by patient, which was prescribed by investigator) to current antipsychotics at this visit. Besides, drug accounting and adverse events will also be recorded at this visit. Patients are maintained on current doses of antipsychotics, and all other medicines.
B.Treatment phase (V2~V3; 2~4 Week finished; 14±3~28±3 Day finished) The vital sign, physical examination, BMI, laboratory tests (at V3), PANSS, EPS (AIMS \& BARS), menstrual function, sexual function (Arizona sexual experience scale), and prolactin will be carried out. Concomitant medication, adverse events, and drug accounting will also be recorded at this visit. Study drug could be titrated with a flexible dose from 7.5 to 30 mg QD. All dose adjustments should be made with the approval of the investigator.
C.Completion visit (V4; 8 Week Finished; 56±7 Day finished, or Early termination) The vital sign, physical examination, pregnancy test, BMI, laboratory tests, PANSS, EPS (AIMS \& BARS), menstrual function, sexual function (Arizona sexual experience scale), prolactin will be carried out. Concomitant medication, adverse events, and drug accounting will also be recorded at this visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female in age between 12 and 65 years old.
- Clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder with DSM-IV criteria.
- Keep stable dosage of the same antipsychotic other than aripiprazole during last one month.
- Who are currently taking antipsychotic drugs and for whom an alteration in medication is clinically reasonable. This includes patients who are stable or who have symptoms that are not optimally controlled or patients experiencing tolerability problems.
- Having antipsychotic-induced symptomatic hyperprolactinemia, weight gain, increased plasma glucose or dyslipidemia judged by the investigator.
Key exclusion criteria (5 listed)
- Pregnant or breast feeding women or planning a pregnancy.
- Patient has a history of hypersensitivity or allergy to investigated drug.
- Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
- Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
- Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
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 |
|---|---|---|
| Abilify (aripiprazole) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2007.
- Derived from this study: PubMed 20732372Chen CK, Huang YS, Ree SC, Hsiao CC. Differential add-on effects of aripiprazole in resolving hyperprolactinemia induced by risperidone in comparison to benzamide antipsychotics. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Dec 1;34(8):1495-9. doi: 10.1016/j.pnpbp.2010.08.012. Epub 2010 Aug 20.
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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.
Chen Chih-Ken, PhD principal investigator
Chang Gung Memorial Hospital, Keelung, Taiwan
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abilify (aripiprazole) in people with Hyperprolactinemia and Weight Gain, run by Genovate Biotechnology Co., Ltd.,.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Oct 2007. 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 Chen Chih-Ken, PhD (+886-2-24313131 ext. 3150, kenchen@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00541554, which also lists 1 linked publication.
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 10 Oct 2007.