Clinical trial NCT02435836: A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia
Official title: An Open-Label Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 631
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.)

Primary outcomes:
measure: Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Mean Change From Baseline in PANSS Positive Sub-scale Score by Week
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Mean Change From Baseline in PANSS Negative Sub-scale Score by Week
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Mean Clinical Global Impression of Improvement (CGI-I) by Week
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline to Last Visit
measure: Percentage of Participants With Vital Signs of Potential Clinical Relevance
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Percentage of Participants With ECG Measurements of Potential Clinical Relevance
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
measure: Percentage of Participants With Laboratory Values of Potential Clinical Relevance
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: