Trial · NCT00706654
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
NCT00706654, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2013-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia. Trials, record NCT00706654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00706654
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
- NCT number
- NCT00706654
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 937 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Schizophrenia
- Interventions
- Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally, Aripiprazole depot 25 or 50 mg, Placebo depot, Placebo tablets
- First posted
- 2008-06-27
- Last updated
- 2026-06-04
- Results first posted
- 2013-08-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 | Baseline to Week 26 | A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score \> 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score \> 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. |
| Secondary | Time to Exacerbation of Psychotic Symptoms/Impending Relapse | Baseline to the end of the study (Week 38) | |
| Secondary | Percentage of Responders up to Week 38 | Baseline to the end of the study (Week 38) | A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. |
| Secondary | Percentage of Patients Achieving Remission | Baseline to the end of the study (Week 38) | A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 | Baseline to Week 26 | Intent-to-treat population: All randomized patients. | Percentage of patients | NUMBER |
| SECONDARY | Time to Exacerbation of Psychotic Symptoms/Impending Relapse | Baseline to the end of the study (Week 38) | Intent-to-treat population: All randomized patients. | Days | MEDIAN |
| SECONDARY | Percentage of Responders up to Week 38 | Baseline to the end of the study (Week 38) | Intent-to-treat population: All randomized patients. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving Remission | Baseline to the end of the study (Week 38) | Intent-to-treat population: All randomized patients. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 | Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | 7.12 | 1.62 | Percentage of patients | |
| Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 | Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | 7.76 | 1.72 | Percentage of patients | |
| Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 | Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | 21.80 | 3.97 | Percentage of patients | |
| Time to Exacerbation of Psychotic Symptoms/Impending Relapse | Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | NA | 95% Confidence Interval NA | Days | |
| Time to Exacerbation of Psychotic Symptoms/Impending Relapse | Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | NA | 95% Confidence Interval NA | Days | |
| Time to Exacerbation of Psychotic Symptoms/Impending Relapse | Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | NA | 95% Confidence Interval NA | Days | |
| Percentage of Responders up to Week 38 | Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | 89.8 | Percentage of patients | ||
| Percentage of Responders up to Week 38 | Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | 89.4 | Percentage of patients | ||
| Percentage of Responders up to Week 38 | Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | 75.2 | Percentage of patients | ||
| Percentage of Patients Achieving Remission | Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | 48.8 | Percentage of patients |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Conversion Phase | STARTED | All Patients | 709 | |
| Conversion Phase | STARTED | Aripiprazole Depot 300 or 400 mg | 0 | |
| Conversion Phase | STARTED | Aripiprazole 10-30 mg Orally | 0 | |
| Conversion Phase | STARTED | Aripiprazole Depot 25 or 50 mg | 0 | |
| Conversion Phase | COMPLETED | All Patients | 614 | |
| Conversion Phase | COMPLETED | Aripiprazole Depot 300 or 400 mg | 0 | |
| Conversion Phase | COMPLETED | Aripiprazole 10-30 mg Orally | 0 | |
| Conversion Phase | COMPLETED | Aripiprazole Depot 25 or 50 mg | 0 | |
| Conversion Phase | NOT COMPLETED | All Patients | 95 | |
| Conversion Phase | NOT COMPLETED | Aripiprazole Depot 300 or 400 mg | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events280
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anxiety | Psychiatric disorders | All Patients - Conversion Phase | 28 | 709 | |
| other | Anxiety | Psychiatric disorders | All Patients - Oral Stabilization Phase | 35 | 842 | |
| other | Anxiety | Psychiatric disorders | Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | 19 | 265 | |
| other | Anxiety | Psychiatric disorders | Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | 13 | 266 | |
| other | Anxiety | Psychiatric disorders | Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | 10 | 131 | |
| other | Schizophrenia | Psychiatric disorders | All Patients - Conversion Phase | 5 | 709 | |
| other | Schizophrenia | Psychiatric disorders | All Patients - Oral Stabilization Phase | 7 | 842 | |
| other | Schizophrenia | Psychiatric disorders | Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | 3 | 265 | |
| other | Schizophrenia | Psychiatric disorders | Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | 3 | 266 | |
| other | Schizophrenia | Psychiatric disorders | Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | 8 | 131 |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients - Conversion Phase | ||
| Total, all-cause mortality | All Patients - Oral Stabilization Phase | ||
| Total, all-cause mortality | Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | ||
| Total, all-cause mortality | Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | ||
| Total, all-cause mortality | Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | ||
| Total, other adverse events | All Patients - Conversion Phase | 140 | 709 |
| Total, other adverse events | All Patients - Oral Stabilization Phase | 177 | 842 |
| Total, other adverse events | Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | 161 | 265 |
| Total, other adverse events | Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | 142 | 266 |
| Total, other adverse events | Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | 74 | 131 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00706654
GET https://conductscience.org/api/trials/v1/NCT00706654/flow?page=2