Study of the effectiveness of OPC-14597 in acute treatment of adults with Schizophrenia.
- Conditions
- SchizophreniaMedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-003805-86-LV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 310
1. Male and female subjects 18 to 65 years of age, inclusive, at the time of informed consent.
2. Subjects with a diagnosis of schizophrenia for at least 1 year as defined by DSM-IV-TR criteria and confirmed by the MINI for Schizophrenia and Psychotic Disorders Studies.
3. Subjects with a stable living environment when not in hospital, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
4. Subjects who would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry. Note: The screening visit (ie, signing the informed consent) must occur no more than 5 days after the date of hospital admission.
5. Subjects who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting BOTH of the following at screening and baseline:
• Currently experiencing an acute exacerbation of psychotic symptoms accompanied by significant deterioration in the subject’s clinical and/or functional status from their baseline clinical presentation with a Positive and Negative Syndrome Scale (PANSS) Total Score = 80 AND
• Specific psychotic symptoms on the PANSS as measured by a score of > 4 on each of the following items (possible scores of 1 to 7 for each item)
• Conceptual disorganization (P2)
• Hallucinatory behavior (P3)
• Suspiciousness/persecution (P6)
• Unusual thought content (G9)
6. Subjects who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the investigator’s opinion.
7. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment, excluding the current episode.
8. Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.
9. BMI = 40 kg/m2 (morbid obesity) at screening.
10. Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
11. Ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 308
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
Sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after the last dose of trial medication. Sexually active females of childbearing potential who do not agree to practice 2
different methods of birth control or remain abstinent during the trial and for 150 days after the last dose of trial medication.
Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP in this trial.
Subjects with improvement of = 30% in total PANSS score between the screening and baseline assessments. -Subjects presenting with a first episode of schizophrenia- Subjects hospitalized for = 30 days out of the last 90 days prior to screening visit. Subjects who have been hospitalized > 5 days for the current acute episode at the time of the screening visit.
Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment.
Subjects who have a history of response to clozapine treatment only.
Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia. Also, subjects with borderline,
paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder or mental retardation.
Subjects experiencing acute depressive symptoms within the past 30 days, that require treatment with an antidepressant.
Subjects with a significant risk of violent behavior; who represent a risk of committing suicide as indicated by any suicidal ideation within the last 1 month or any suicidal behaviors within the last
year; or who present a serious risk of suicide.
Subjects with clinically significant tardive dyskinesia
Subjects with severe akathisia.
Subjects who have met DSM-IV-TR criteria for substance abuse with the past 3 months prior to screening or dependence within the past 6 months; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the overall efficacy of aripiprazole IM depot as acute treatment in subjects with schizophrenia.;Secondary Objective: To evaluate the safety and tolerability of aripiprazole IM depot as acute treatment in subjects with schizophrenia;Primary end point(s): Primary Outcome Variable:<br>• Mean change from baseline to endpoint in PANSS Total<br>Score;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Key Secondary Outcome Variable:<br>• Mean change from baseline to endpoint in Clinical Global<br>Impression - Severity scale (CGI-S)<br><br>Other Secondary Outcome Variables:<br>Efficacy:<br>• Mean change from baseline to endpoint in PANSS positive<br>and negative subscales<br>• Mean change from baseline to endpoint in Personal and<br>Social Performance Scale (PSP)<br>• Mean Clinical Global Impression - Improvement<br>scale (CGI-I) score at endpoint<br>• Responder rate at endpoint (defined by = 30% reduction in<br>Total PANSS score);Timepoint(s) of evaluation of this end point: week 12