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The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole IM depot injection | Experimental | 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 prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, 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. Oral aripiprazole was available as rescue medication if necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole (Abilify®) IM Depot Injection | Drug | 400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg. Number of injections: 6. Participants have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2014. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Inpatient Psychiatric Hospitalization Rates | 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. | Retrospective period Months 4-6; Prospective period Months 4-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Peters-Strickland | Otsuka Pharmaceutical Development & Commercialization, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruges | 8310 | Belgium | ||||
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Oral Aripirazole (Phase A) |
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| Oral aripiprazole | Drug | Oral aripiprazole tablets 10-15 mg/day (up to 30 mg/day). |
|
| Baseline, Week 24 |
| Change From Baseline in PANSS Positive and Negative Subscale Scores | 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. | Baseline, Week 24 |
| Clinical Global Impression of Severity (CGI-S) Score | 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. | Baseline, Week 24 |
| Clinical Global Impression of Improvement (CGI-I) Score | 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. | Baseline, Week 24 |
| Brussels |
| 1160 |
| Belgium |
| Kortenberg | 3070 | Belgium |
| Liège | 4000 | Belgium |
| Lovech | 5500 | Bulgaria |
| Novi Iskar | 1282 | Bulgaria |
| Pazardzhik | 4400 | Bulgaria |
| Tzerova Koria | 5047 | Bulgaria |
| Penticton | British Columbia | V2A 4M4 | Canada |
| Chatham | Ontario | N7M 5L9 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| Aripiprazole IM Depot Treatment Phase(B) |
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| Aripiprazole IM Depot Extension Phase(C) |
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Baseline measures are based on all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Inpatient Psychiatric Hospitalization Rates | 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. | Due to the low number of enrolled patient and the sponsor's early termination of the study, the primary efficacy endpoint was not evaluated. | Posted | Retrospective period Months 4-6; Prospective period Months 4-6 |
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| Secondary | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | 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. | Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated. | Posted | Baseline, Week 24 |
| |||||||||||||||||||||||
| Secondary | Change From Baseline in PANSS Positive and Negative Subscale Scores | 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. | Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated. | Posted | Baseline, Week 24 |
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| Secondary | Clinical Global Impression of Severity (CGI-S) Score | 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. | Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated. | Posted | Baseline, Week 24 |
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| Secondary | Clinical Global Impression of Improvement (CGI-I) Score | 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. | Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated. | Posted | Baseline, Week 24 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Aripiprazole (Phase A) | 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. | 0 | 19 | 4 | 19 | ||
| EG001 | Aripiprazole IM Depot (Phase B) | 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. | 1 | 19 | 10 | 19 | ||
| EG002 | Aripiprazole IM Depot (Phase C) | 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. | 0 | 3 | 1 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug-induced liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Schizophrenia | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus | Metabolism and nutrition disorders |
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| Insomnia | Psychiatric disorders |
| |||
| Fatigue | General disorders |
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| Flatulence | Gastrointestinal disorders |
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| Irritability | General disorders |
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| Bronchitis | Infections and infestations |
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| Alanine aminotransferase increased | Investigations |
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| Aspartate aminotransferase increased | Investigations |
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| Blood creatine phosphokinase increased | Investigations |
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| Blood glucose increased | Investigations |
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| Blood triglycerides increased | Investigations |
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| Gamma-glutamyltransferase increased | Investigations |
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| Weight decreased | Investigations |
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| Back pain | Musculoskeletal and connective tissue disorders |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
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| Somnolence | Nervous system disorders |
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| Psychotic disorder | Psychiatric disorders |
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| Palpitations | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs | Otsuka Pharmaceutical Development & Commercialization, Inc. | 800-562-3974 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Subject withdrew consent |
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