Sexual DysfunctionPhase 4NCT01742390
A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders
A Phase 4 study testing Aripiprazole and risperidone or paliperidone in people with Sexual Dysfunction and Hyperprolactinemia, run by Si Tianmei at 2 sites in China.
Trial summary
This trial designed to investigate the effect of switching to aripiprazole from risperidone or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Sexual Dysfunction, Hyperprolactinemia
- What is being tested?
- Aripiprazole and risperidone or paliperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2013to Jun 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 12-55 years (male), 12-40 (female)
- Diagnosis: Schizophrenia spectrum disorders \& bipolar spectrum disorders (only Korea) by DSM-IV-TR
- Receiving RIS or PALI with stable dose for > 1 month by their physician;
- Prolactin level Adult: > 20 ng/ml (male), 25 ng/ml (female) Child/Adolescent: > 20 ng/ml (male, female)
- Children and adolescents (age: 12~17 years) having more than one sexual system dysfunction measured by 5 of the 48 UKU items (galactorrhoea, gynecomastia and erectile dysfunction for male, galactorrhea, amenorrhoea/oligomenorrhoea, and dry vagina for female) or Adults (age: 18~55 years) who are considered to have sexual/reproductive dysfunction if they had either a total score of 19 or higher; a score of 5 or higher on one question; or a score of 4 or higher on 3 questions.
- Subjects who have consented to participate by signing an informed consent form.
- -
Who cannot join
- Medical disorder or psychiatric comorbidity or condition known to affect prolactin, sex hormone balance or bone metabolism (i.e., unstable medical disease, Cushing's disease, chronic renal failure, thyroid dysfunction, eating disorder)
- History of hematological and/or solid malignancies
- Physical or functional obstruction to food intake or impaired digestive/absorptive function
- Known hypersensitivity to any study medication (risperidone, paliperidone, and aripiprazole)
- Insulin requiring diabetes mellitus or poorly controlled diabetes mellitus (HbA1c > 9% or change of antidiabetics treatment within the 12weeks prior to screening)
- Uncontrolled hypertension (SBP/DBP 140/90 mmHg), congestive heart failure (NYHA class III or IV), other significant cardiovascular illness (myocardial infarction, unstable angina, cardiac arrhythmia etc.)
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- Baseline QTc interval of > 450 msec
- Hepatic and/or renal dysfunction
- 1) Bilirubin level ≥ 1.5 upper normal limits 2) AST/ALT ≥ 3 UNL or 3) Serum creatinine ≥ 1.5 9. Any patient hospitalized for acute exacerbation of their condition within 2 months of randomization 10. Recent (within the past 1 month) or planned treatment with prohibited medications in the protocol
- -
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Institute of mental health, Peking University
Beijing, Beijing Municipality, 100191
Tianmei Si, MD., 8610-82801948, si.tian-mei@163.cm
Tianmei Si, MD.
- Recruiting
The first hospital of Hebei Province University
Shijiazhuang, Hebei, 050000
Xueyi Wang, Professor, 0311-85917290
Xueyi Wang
About this study
This trial designed to investigate the effect of switching to aripiprazole from risperidone or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders.
- Conditions
- Sexual Dysfunction, Hyperprolactinemia
- Being tested
- Aripiprazole, risperidone or paliperidone
- Keywords
- schizophrenia, risperidone, paliperidone, aripiprazole
- Medical subject headings
- Sexual Dysfunction, Physiological, Hyperprolactinemia, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
risperidone or paliperidoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Experimental | Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI) Receives: Drug: Aripiprazole |
| risperidone or paliperidone | Active comparator | Stay on risperidone (RIS) or paliperidone (PALI) Receives: Drug: risperidone or paliperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Si Tianmei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Si Tianmei, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742390
- Sponsor's protocol ID
- ARI_IIT_01/02
- Status last verified
- Mar 2013
- First submitted
- 22 Nov 2012
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01742390
- Acronym / sponsor ID
- ARI_IIT_01/02
- Conditions
- Sexual Dysfunction, Hyperprolactinemia
- Keywords
- schizophrenia, risperidone, paliperidone, aripiprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Si TianmeiUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 5 Dec 2012 (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 trial designed to investigate the effect of switching to aripiprazole from risperidone or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: AripiprazolePlateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI) |
| risperidone or paliperidone | Active comparator | Drug: risperidone or paliperidoneStay on risperidone (RIS) or paliperidone (PALI) |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age: 12-55 years (male), 12-40 (female)
- Diagnosis: Schizophrenia spectrum disorders \& bipolar spectrum disorders (only Korea) by DSM-IV-TR
- Receiving RIS or PALI with stable dose for > 1 month by their physician;
- Prolactin level Adult: > 20 ng/ml (male), 25 ng/ml (female) Child/Adolescent: > 20 ng/ml (male, female)
- Children and adolescents (age: 12~17 years) having more than one sexual system dysfunction measured by 5 of the 48 UKU items (galactorrhoea, gynecomastia and erectile dysfunction for male, galactorrhea, amenorrhoea/oligomenorrhoea, and dry vagina for female) or Adults (age: 18~55 years) who are considered to have sexual/reproductive dysfunction if they had either a total score of 19 or higher; a score of 5 or higher on one question; or a score of 4 or higher on 3 questions.
Key exclusion criteria (10 listed)
- Medical disorder or psychiatric comorbidity or condition known to affect prolactin, sex hormone balance or bone metabolism (i.e., unstable medical disease, Cushing's disease, chronic renal failure, thyroid dysfunction, eating disorder)
- History of hematological and/or solid malignancies
- Physical or functional obstruction to food intake or impaired digestive/absorptive function
- Known hypersensitivity to any study medication (risperidone, paliperidone, and aripiprazole)
- Insulin requiring diabetes mellitus or poorly controlled diabetes mellitus (HbA1c > 9% or change of antidiabetics treatment within the 12weeks prior to screening)
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 |
|---|---|---|
| AripiprazolePlateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI) | Drug | Aripiprazole |
| risperidone or paliperidone | Drug | risperidone or paliperidone |
Primary outcome
Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks
Time frame: 12 weeks
1 secondary outcome
Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole and risperidone or paliperidone in people with Sexual Dysfunction and Hyperprolactinemia, run by Si Tianmei at 2 sites 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 7 inclusion and 10 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 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianmei Si, MD. (861082801948, si.tian-mei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks (time frame: 12 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 14 Mar 2013; AzTrials last refreshed its copy on 1 Nov 2026.