A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia
Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Aripiprazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
The primary objective of the study was to determine the safety of aripiprazole administered
long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects
with chronic or first episode of schizophrenia. Information on the continued efficacy of
aripiprazole was also gathered in this long-term trial (until 31 Dec 2012 or until
aripiprazole was otherwise available through marketed means and/or reimbursed).
Clinical Details
Official title: An Open-Label Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Total score on the Positive and Negative Syndrome Scales measuring symptom severity (PANSS-total)Total Positive score on the Positive and Negative Syndrome Scales measuring symptom severity(PANSS-positive) Total Negative score on the Positive and Negative Syndrome Scales measuring symptom severity (PANSS-Negative) Clinical Global Impression (CGI)-severity score - clinician rating of severity of illness Clinical Global Impression (CGI)-improvement score - clinician rating of improvement relative to baseline Montgomery and Asberg Depression Rating Scale (MADRS)-score measuring depression Simpson-Angus Scale Score (SAS), assessing parkinsonian and related extrapyramidal side effects Abnormal Involuntary Movement Scale (AIMS) Score Barnes Akathisia Rating Scale Score Subjects with changes in vital signs reported as Treatment Emergent Adverse Events Subjects with changes in electrocardiogram results reported as Treatment Emergent Adverse Events Subjects with changes in laboratory values reported as Treatment Emergent Adverse Events Adverse events (AEs) Subjects with changes in body weight reported as Treatment Emergent Adverse Events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Complete a Prior Study: each patient must meet one of the following conditions for
completion of the prior study:
- A patient who has completed 52 weeks of post-randomization treatment in the
prior double blind study (31-97-301 or 31-98-304-01) is eligible, with no
further qualifications.
- A patient who was early-terminated from the study 31-97-301 or 31-98- 304-01 for
either of the following two reasons is eligible to enter this open label study
with no minimal required duration of prior double-blind participation:
- Early termination was due to a marked deterioration of clinical status and
no serious adverse events (SAE) other than hospitalization has occurred.
The marked clinical deterioration must be documented by at least a
one-point increase in CGI-Severity score from the baseline and a score of 6
(much worse) or 7 (very much worse) in CGI-Global Improvement at the time
of termination, or
- Early termination was due to a non-serious AE requiring discontinuation of
the study drug
- A patient who was early terminated after a minimum of 4 weeks' participation in
the double-blind treatment in study 31-97-301 or 31-98- 304-01 and the reason
for early termination was withdrawal of consent due to lack of effect but not
marked deterioration. This must be documented by no change from baseline in the
CGI-Severity score and a score of 4 (no change) or 5 (minimally worse) on the
CGI-Global Improvement scale.
2. Signing of Informed Consent Form: Prior to any procedure or drug administration, each
patient must sign an informed consent form. In addition, if required by the Ethical
Committee, each patient's next-of-kin or responsible caregiver will co-sign the
patient's consent form or a separate consent form.
Exclusion Criteria:
1. Patients suffering from any significant somatic disease or medical problem that would
obscure the results of treatment, or that might require frequent changes of
concomitant medication.
2. Patients with any acute or unstable medical condition requiring pharmacotherapy,
other than schizophrenia.
3. Patients with an abnormal laboratory test value in the most recent analysis (from the
study 31-97-301 or 31-98-304-01) which is considered by the investigator as
presenting a significant risk to the patient for continuing treatment with
aripiprazole.
4. Patients who were early-terminated from the prior double-blind studies (31-97-301 or
31-98-304-01) due to a serious adverse event (SAE) other than worsening of psychosis
or hospitalization.
5. Female patients of child bearing potential with a positive serum pregnancy test at
the baseline (last visit of prior study) of this open-label follow-on study.
6. Patients who have positive result in the urine screen for drugs of abuse (except for
cannabis or medically-prescribed analgesics or benzodiazepines.)
Locations and Contacts
Additional Information
Starting date: April 1998
Last updated: May 1, 2015
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