A blinded study looking at the efficacy, safety and tolerability of aripirazole in Adolescent Patients with Schizophrenia.
- Conditions
- Schizophrenia in Adolescent PatientsMedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2010-020987-39-Outside-EU/EEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 138
Inclusion Criteria Assessed at Screening
1. Study specific written informed consent/assent obtained from the parent/guardian or legal representative, as applicable for local laws prior to the initiation of any protocol-required procedures. In addition, the subject must provide informed assent at screening and must be able to understand that he or she can withdraw from the study at any time. All informed consent/assent procedures
must be in accordance with the study center’s institutional review board/ethics committee (IRB/IEC) and local regulatory requirements.
2. Male and female subjects aged 13 to 17 years, inclusive, at the time of informed consent/assent until randomization in Phase 3.
3. Subjects with a current diagnosis of schizophrenia, and a history of the illness for at least 6 months prior to screening.
4. Subjects who in the investigator’s judgment, require treatment with antipsychotic medication(s).
5. Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics, according to the investigator’s clinical judgment.
6. Subjects who are currently being treated with oral antipsychotics other than clozapine. Subjects who have been without antipsychotic treatment for no more than 3 weeks prior to screening will be considered as being treated currently for the purpose of determining eligibility for this trial.
7. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.
8. Inpatient or outpatient status.
9. Ability of the subject, the subject’s parent/guardian or the legal representative, as applicable for local laws to comprehend and satisfactorily comply with the protocol
requirements (including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medications), to read and understand the written word in order to complete subject-reported outcomes measures, and to reliably rate assessment scales.
10. Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double barrier methods of contraception (or can confirm abstinence), and must not be pregnant or lactating.
11. Subjects who are receiving antipsychotic(s) other than aripiprazole must be cross-titrated to aripiprazole monotherapy over 4 to 6 weeks using an initial dose of 2 mg/day in Phase 1 to achieve a recommended aripiprazole monotherapy minimum target dose of 10 mg/day in order to enter Phase 2, but higher doses may be achieved based on the subject’s clinical need and investigator judgment. Subjects who have received or are receiving clozapine are excluded from the study.
12. Subjects who are treated with non-branded generic aripiprazole must also be cross-titrated to achieve a 10 mg target dose of study aripiprazole. Also, the total dose of the generic aripiprazole and study aripiprazole (at any given time in Phase 1) cannot exceed a total of 30 mg/day.
13. By the end of screening, eligible subjects who are receiving oral branded aripiprazole (ie, Abilify™) monotherapy at a dose between 10 and 30 mg/day for treatment of schizophrenia at screening can enter Phase 2 directly.
14. Adequate washout of prohibited concomitant medications prior to entry into Phase 2, including = 14 days for prohibited mood stabilizers, = 14 days for prohibited antidepressants [= 28 days for fluoxetine or Symbyax (ol
Sex and Reproductive Status
1. Sexually active males who are not practicing double-barrier birth control or who will not remain abstinent during the study and for 90 days following the last dose of study medication, or sexually active females of childbearing potential who are not practicing double-barrier birth control or who will not remain abstinent during the study and for 30 days following the last dose of study medication. Abstinence will be permitted if it is confirmed and documented at every study visit. If employing birth control, two of the following precautions must be used:
vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), birth control pill, birth control depot injections, birth control implant, condom or sponge with spermicide.
2. Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving study drug.
Target Disease
3. Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including an Axis I (DSM-IV-TR) diagnosis of schizoaffective disorder, major depressive disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD. Subjects with a diagnosis of ADD/ADHD and treated with stimulants or other ADD/ADHD medications within 1 year are prohibited.
4. amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (ie, medication, illicit drug use, etc.).
5. Subjects with attention deficit disorder or attention deficit hyperactivity disorder and/or the patient was on stimulant treatment for any period of time over the last one year prior to screening.
6. Subjects with a clinical presentation and/or history of any neurodevelopmental disorder except Tourette’s syndrome.
7. Subjects experiencing acute depressive symptoms within the past 30 days prior to screening that, according to the investigator’s judgment, require treatment with an antidepressant.
8. Subjects with schizophrenia that is considered treatment resistant to antipsychotic medication, including relapse while on adequate doses of aripiprazole, by history.
9. Subjects who are currently receiving clozapine or have received clozapine, regardless of dose or duration, at any time in the past are ineligible for entry into the study.
Medical History and Concurrent Disease
10. Subjects who have a significant risk of committing suicide based on history (eg, suicide attempt in the past 1 year) or routine psychiatric status examination, or who have an answer of yes” on Questions 4 or 5 (current or over the last 30 days) on the suicidal ideation section of the baseline screening version of the C-SSRS.
11. Subjects who have met DSM-IV-TR criteria for substance dependence (including alcohol and
benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.
12. Subjects who have epilepsy, a history of seizures (except
for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions that would expose them to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the c
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method