Trial · NCT00731549
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
NCT00731549, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2014-11-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia. Trials, record NCT00731549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00731549
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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
- NCT00731549
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,081 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Schizophrenia
- Interventions
- Aripiprazole IM Depot
- First posted
- 2008-08-11
- Last updated
- 2014-11-26
- Results first posted
- 2014-11-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Baseline to Week 52/Last visit | "Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; 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): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here. |
| Secondary | Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria. | Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal) | "Impending relapse criteria" was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of \>4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score \>4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage. |
| Secondary | Percentage of Participants Achieving Remission. | Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity. |
| Secondary | Percentage of Participants Stable at Baseline and Remaining Stable at Week 28. | Baseline to Week 28 | "Stable" was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; 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): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here. |
| Secondary | Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse. | Baseline to Week 52 | Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy. |
| Secondary | Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score. | Baseline, Weeks 12, 24, 52 and last visit | PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. |
| Secondary | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score. | Baseline, Weeks 12, 24, 52 and last visit | To assess CGI-S, the rater or physician will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. |
| Secondary | Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales. | Baseline, Weeks 12, 24, 52 and last visit | PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. |
| Secondary | Mean Clinical Global Impression of Improvement (CGI-I) Score. | Weeks 2, 4, 12, 24, 52 and last visit | To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. |
| Secondary | Percentage of Participants Who Discontinued Due to All Causes. | Baseline to Week 52 | Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Baseline to Week 52/Last visit | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria. | Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal) | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Remission. | Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Stable at Baseline and Remaining Stable at Week 28. | Baseline to Week 28 | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse. | Baseline to Week 52 | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed had available assessments for evaluation of exacerbation of psychotic symptoms/impending relapse. | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score. | Baseline, Weeks 12, 24, 52 and last visit | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score. | Baseline, Weeks 12, 24, 52 and last visit | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales. | Baseline, Weeks 12, 24, 52 and last visit | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here. | Units on a scale | MEAN |
| SECONDARY | Mean Clinical Global Impression of Improvement (CGI-I) Score. | Weeks 2, 4, 12, 24, 52 and last visit | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Discontinued Due to All Causes. | Baseline to Week 52 | All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Baseline (N=1075) | 100 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 2 (N=1023) | 99.02 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 4 (N=1045) | 99.14 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 8 (N=1009) | 98.51 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 12 (N=988) | 97.47 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 16 (N=951) | 98.42 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 20 (N=919) | 98.15 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 24 (N=880) | 99.20 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 28 (N=854) | 98.95 | Percentage of participants | |
| Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). | Aripiprazole 400/300 mg IM Depot | Week 32 (N=838) | 99.16 | Percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aripiprazole 400/300 mg IM Depot | 1,081 | |
| Overall Study | COMPLETED | Aripiprazole 400/300 mg IM Depot | 858 | |
| Overall Study | NOT COMPLETED | Aripiprazole 400/300 mg IM Depot | 223 |
Source ClinicalTrials.gov
Adverse events71
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 | Nasopharyngitis | Infections and infestations | Aripiprazole 400/300 mg IM Depot | 76 | 1,081 | |
| other | Headache | Nervous system disorders | Aripiprazole 400/300 mg IM Depot | 82 | 1,081 | |
| other | Anxiety | Psychiatric disorders | Aripiprazole 400/300 mg IM Depot | 73 | 1,081 | |
| other | Insomnia | Psychiatric disorders | Aripiprazole 400/300 mg IM Depot | 71 | 1,081 | |
| serious | Anaemia | Blood and lymphatic system disorders | Aripiprazole 400/300 mg IM Depot | 1 | 1,081 | |
| serious | Atrial fibrillation | Cardiac disorders | Aripiprazole 400/300 mg IM Depot | 1 | 1,081 | |
| serious | Cardiac arrest | Cardiac disorders | Aripiprazole 400/300 mg IM Depot | 1 | 1,081 | |
| serious | Cardiac failure | Cardiac disorders | Aripiprazole 400/300 mg IM Depot | 1 | 1,081 | |
| serious | Cardiac failure acute | Cardiac disorders | Aripiprazole 400/300 mg IM Depot | 1 | 1,081 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Aripiprazole 400/300 mg IM Depot | 1 | 1,081 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aripiprazole 400/300 mg IM Depot | ||
| Total, other adverse events | Aripiprazole 400/300 mg IM Depot | 254 | 1,081 |
| Total, serious adverse events | Aripiprazole 400/300 mg IM Depot | 95 | 1,081 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00731549
GET https://conductscience.org/api/trials/v1/NCT00731549/results?page=2