| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
| Schizophrenia is a debilitating mental illness. Hallucinations and delusions most characteristic symptoms; however, social withdrawal; lack of emotion, energy and motivation may also be present. |
|
| E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10001064 |
| E.1.2 | Term | Acute schizophrenia |
| E.1.2 | System Organ Class | 100000004873 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To compare the efficacy of each of three fixed doses
of OPC-34712 with placebo in the treatment of acute
schizophrenia in adults. |
|
| E.2.2 | Secondary objectives of the trial |
To compare the safety and tolerability of each of
three fixed doses of OPC-34712 with placebo in the treatment
of acute schizophrenia in adults. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subjects who are able to provide written informed consent (as
required by IRB/IEC) prior to the initiation of any protocol-required
procedures.
2. Ability, in the opinion of the principal 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.
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. Male and female subjects 18 to 65 years of age, inclusive, at the time
of informed consent with a diagnosis of schizophrenia as defined by
DSM-IV-TR criteria and confirmed by the MINI for
Schizophrenia and Psychotic Disorders Studies.
5. Subjects who would benefit from hospitalization or continued
hospitalization for treatment of a current acute relapse of schizophrenia
at trial entry.
6. Subjects who are experiencing an acute exacerbation of psychoticsymptoms and marked deterioration of usual function
7. 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.
8. Subjects with a history of relapse and/or exacerbation of symptoms
when they are not receiving antipsychotic treatment, excluding the
current episode.
9. Subjects willing to discontinue all prohibited psychotropic medications
to meet protocol-required washouts prior to and during the trial period |
|
| E.4 | Principal exclusion criteria |
1. Sexually active females of childbearing potential and male subjects
who are not practicing two different methods of birth control with their
partner during the trial and for 30 days
after the last dose of trial medication or who will not remain abstinent
during the trial and for 30 days after the last dose.
2. Females who are breast-feeding and/or who have a positive
pregnancy test result prior to receiving trial drug
3. Subjects presenting with a first episode of schizophrenia based on the
clinical judgment of the investigator.
4. Subjects who have been hospitalized > 21 days for the current acute
episode at the time of the Baseline visit, excluding hospitalization for
psychosocial reasons.
5. Subjects with improvement of greater than or equal to 30% in total
BPRS score between the screening and baseline assessments.
6. Subjects with schizophrenia who are considered resistant/refractory
to antipsychotic treatment by history or who have a history of failure to
respond to clozapine or response to clozapine treatment only.
7. Subjects with a current DSM-IV-TR Axis I diagnosis other than
schizophrenia including, but not limited to schizoaffective disorder, MDD,
bipolar disorder, post-traumatic stress disorder, anxiety
disorders, delirium, dementia, amnestic or other cognitive disorders.
Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid,
or antisocial personality disorder.
8. Subjects experiencing acute depressive symptoms within the past 30
days, according to the investigator's opinion, that require treatment with
an antidepressant.
9. Subjects with a significant risk of violent behavior; who represent a
risk of committing suicide as indicated by any suicidal ideation within
the last 6 months or any suicidal behaviors within the last two years; or
who in the clinical judgment of the investigator present a serious risk of
suicide.
10. Subjects with clinically significant tardive dyskinesia at enrollment,
as determined by a score of greater than or equal to 3
on Item 8 of the AIMS at Screening.
11. Subjects with a score of 5 on the BARS global clinical assessment of
akathisia at Screening or Baseline.
12. Subjects who have met DSM-IV-TR criteria for substance abuse or
dependence within the past 180 days
13. Subjects with hypothyroidism or hyperthyroidism (unless condition
has been stabilized with medications for at least the past 90 days)
and/or an abnormal result for free T4 at Screening.
14. Subjects who currently have clinically significant neurological,
hepatic, renal, metabolic, hematological, immunological, cardiovascular,
pulmonary, or gastrointestinal disorders such as any history of
myocardial infarction, congestive heart failure, HIV seropositivestatus/acquired immunodeficiency syndrome, or chronic hepatitis B or C.
15. Subjects with IDDM (ie, any subjects using insulin) are excluded.
16. Subjects with uncontrolled hypertension (DBP > 95 mmHg in any
position) or symptomatic hypotension, or orthostatic hypotension which
is defined as a decrease of greater than or equal to 30 mmHg in SBP
and/or a decrease of greater than or equal to 20 mmHg in DBP after at
least 3 minutes standing compared to the previous supine blood
pressure, OR development of symptoms.
17. Subjects with known ischemic heart disease or history of myocardial
infarction, congestive heart failure, angioplasty, stenting, or coronary
artery bypass surgery.
18. Subjects with epilepsy or a history of seizures
19. Subjects who received ECT within 60 days of screening.
20. Subjects who received trial drug (brexpiprazole or placebo) in any
previous brexpiprazole trial.
21. Subjects with a history of true allergic response (ie, not intolerance)
to more than one class of medications.
22. Any subject who, in the opinion of the investigator or medical
monitor, should not participate in the trial.
E.5 |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| •The change in Positive and Negative Syndrome Scale (PANSS) Total Score |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Baseline visit to Week 6/Early Termination |
|
| E.5.2 | Secondary end point(s) |
| Change in Clinical Global Impression - Severity of Illness scale (CGI-S) score |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Baseline visit to Week 6/Early Termination |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 13 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Bulgaria |
| Chile |
| Colombia |
| Croatia |
| India |
| Mexico |
| Philippines |
| Russian Federation |
| South Africa |
| Taiwan |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The End of Trial Date is defined as the last Date of Contact or the Date of Final Contact Attempt from the Post-treatment Follow-up eCRF page for the last subject completing or withdrawing from the trial. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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