Trial Outcomes & Findings for Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole (NCT NCT01509053)
NCT ID: NCT01509053
Last Updated: 2015-03-04
Results Overview
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.
TERMINATED
PHASE3
30 participants
Retrospective period Months 4-6; Prospective period Months 4-6
2015-03-04
Participant Flow
This study included a Tolerability Assessment Phase A (if applicable), an Open-Label Aripiprazole IM Depot Phase B and an Open-Label Aripiprazole IM Depot Extension Phase C.
Participant milestones
| Measure |
Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection
Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
|
|---|---|
|
Oral Aripirazole (Phase A)
STARTED
|
19
|
|
Oral Aripirazole (Phase A)
COMPLETED
|
8
|
|
Oral Aripirazole (Phase A)
NOT COMPLETED
|
11
|
|
Aripiprazole IM Depot Treatment Phase(B)
STARTED
|
19
|
|
Aripiprazole IM Depot Treatment Phase(B)
COMPLETED
|
3
|
|
Aripiprazole IM Depot Treatment Phase(B)
NOT COMPLETED
|
16
|
|
Aripiprazole IM Depot Extension Phase(C)
STARTED
|
3
|
|
Aripiprazole IM Depot Extension Phase(C)
COMPLETED
|
0
|
|
Aripiprazole IM Depot Extension Phase(C)
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection
Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
|
|---|---|
|
Oral Aripirazole (Phase A)
Sponsor discontinued study
|
11
|
|
Aripiprazole IM Depot Treatment Phase(B)
Adverse Event
|
1
|
|
Aripiprazole IM Depot Treatment Phase(B)
Sponsor discontinued study
|
13
|
|
Aripiprazole IM Depot Treatment Phase(B)
Subject was withdrawn by investigator
|
1
|
|
Aripiprazole IM Depot Treatment Phase(B)
Subject withdrew consent
|
1
|
|
Aripiprazole IM Depot Extension Phase(C)
Sponsor discontinued study
|
3
|
Baseline Characteristics
Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
Baseline characteristics by cohort
| Measure |
All Participants
n=30 Participants
Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
|
|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Retrospective period Months 4-6; Prospective period Months 4-6Population: Due to the low number of enrolled patient and the sponsor's early termination of the study, the primary efficacy endpoint was not evaluated.
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.
The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.
The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.
The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.
The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
Outcome measures
Outcome data not reported
Adverse Events
Oral Aripiprazole (Phase A)
Aripiprazole IM Depot (Phase B)
Aripiprazole IM Depot (Phase C)
Serious adverse events
| Measure |
Oral Aripiprazole (Phase A)
n=19 participants at risk
Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot.
|
Aripiprazole IM Depot (Phase B)
n=19 participants at risk
In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
|
Aripiprazole IM Depot (Phase C)
n=3 participants at risk
Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
|
|---|---|---|---|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
Other adverse events
| Measure |
Oral Aripiprazole (Phase A)
n=19 participants at risk
Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot.
|
Aripiprazole IM Depot (Phase B)
n=19 participants at risk
In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
|
Aripiprazole IM Depot (Phase C)
n=3 participants at risk
Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/19
|
5.3%
1/19
|
33.3%
1/3
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19
|
15.8%
3/19
|
0.00%
0/3
|
|
General disorders
Fatigue
|
5.3%
1/19
|
10.5%
2/19
|
0.00%
0/3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
General disorders
Irritability
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Investigations
Blood glucose increased
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Investigations
Weight decreased
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Nervous system disorders
Somnolence
|
5.3%
1/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/3
|
Additional Information
Medical Affairs
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place