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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental | Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI) |
|
| risperidone or paliperidone | Active Comparator | Stay on risperidone (RIS) or paliperidone (PALI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX | 12 weeks |
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Inclusion Criteria:
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.
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Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianmei Si, MD. | Contact | 861082801948 | si.tian-mei@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of mental health, Peking University | Not yet recruiting | Beijing | Beijing Municipality | 100191 | China |
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| risperidone or paliperidone | Drug |
|
| The first hospital of Hebei Province University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
|
| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D006966 | Hyperprolactinemia |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D018967 | Risperidone |
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D007555 | Isoxazoles |
| D001393 | Azoles |
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