Trial · NCT01710709
Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
NCT01710709, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2018-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder. Trials, record NCT01710709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01710709
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
- NCT number
- NCT01710709
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 748 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Bipolar I
- Interventions
- Aripiprazole
- First posted
- 2012-10-19
- Last updated
- 2018-09-21
- Results first posted
- 2018-08-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Up to Week 52 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP). AEs were assessed as a criteria for safety and tolerability. |
| Primary | Injection Site Pain Measured by the Visual Analog Scale (VAS) | Up to Week 52 | Injection-site pain was evaluated by mean visual analog scale (VAS) scores as reported by the participant after each injection at visits where an injection occurred. Ratings ranged from 0 (no pain) to 100 (unbearably painful). |
| Primary | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | Up to Week 52 | Standard safety variables to be analyzed included clinical laboratory tests. Incidence of treatment emergent adverse events (TEAEs) of potential clinical relevance included abnormal values in serum chemistry, hematology, urinalysis, and other laboratory test that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as serious adverse event/adverse events (SAE/AEs) and are reported in the SAE/other AE section of this report. |
| Primary | Number of Participants With Clinically Significant Abnormal Vital Signs | Up to Week 52 | TEAEs of potential clinical relevance included abnormal values in body weight, systolic and diastolic blood pressure, heart rate, and body temperature that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report. |
| Primary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs) | Up to Week 52 | Twelve-lead ECGs were recorded at specified visits. For each time point, three 12-lead ECG recordings were obtained approximately 5 minutes apart. Additional 12-lead ECGs were permitted to be obtained at the investigator's discretion and were to always be obtained in the event of an early termination. The ECGs were evaluated at the investigational site to determine the participant's eligibility and to monitor safety during the trial. |
| Primary | Extrapyramidal Symptoms Will be Assessed by Mean Change From Baseline on Abnormal Involuntary Movement Scale(AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Only Used in Japan) and Barnes Akathisia Rating Scale (BARS) | Baseline, Week 28, and Week 52 | AIMS: 10 items described dyskinesia signs; 0-absence/no awareness; 4-severe condition/severe distress. Total score for Items 1-10 ranges from 0 to 40; a higher score reflects severe condition. SAS:Consisted of 10 parkinsonism signs;1-no symptoms;5-severe.Total score for Items 1-10 ranges from 1 to 50;a higher score reflects severe condition.DIEPSS:A 9-item rating scale (8 assessed individual symptoms \[4 categories of parkinsonism, akathisia, dystonia \& dyskinesia\]+1 assessed general severity) was used;0-no symptoms/normal, 4-severe.Total score (8 individual symptom items) was in range of 0 to 32 (a higher score reflects severe condition).BARS:Consisted of 4 items related to akathisia:objective observation, subjective feelings of restlessness, distress, global clinical evaluation.Only BARS global clinical assessment score has been presented and rated using scale:0-absence of symptoms;5-severe akathisia.Total BARS global score ranges from 0 to 5,a higher score reflects severe condition. |
| Primary | Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS) | Up to Week 52 | Suicidality was monitored throughout the trial using the C-SSRS at every visit. The C-SSRS scale consisted of a screening/baseline evaluation that assessed the participant's lifetime experience and experience over the last 90 days with suicide events and suicidal ideation and a post-baseline/ "Since Last Visit" evaluation that focused on suicidality since the last trial visit. |
| Primary | Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating | Up to Week 52 | Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe) . The participant indicated the degree of pain at the most recent injection site using a VAS. Ratings ranged from 0 (no pain) to 100 (unbearably painful). Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. These assessments occurred at trial visits where injections occurred (scheduled and unscheduled), beginning with the first dose of open-label aripiprazole IM depot administered at the final visit of the Oral Stabilization Phase and continued through the last injection prior to the end of the IM Depot Maintenance Phase/Early termination (ET) visit (ie, evaluations were not done at end of the IM Depot Maintenance Phase/ET visit). |
| Secondary | Percentage of Participants Who Remained Stable at End of Treatment in Phase C | Up to Week 52 | The secondary objective was to evaluate the efficacy, as measured by the percentage of stable participants at baseline who remained stable at the end of treatment in the IM depot maintenance phase, of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to subjects with bipolar I disorder. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | Up to Week 52 | IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. TEAEs = Treatment-emergent adverse events. discount. = discontinued (used in the table below) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Injection Site Pain Measured by the Visual Analog Scale (VAS) | Up to Week 52 | All participants who received at least one dose of aripiprazole IM depot in Phase C. It is equivalent to safety set (SAF) for Phase C.~Number analyzed = Total number of participants with at least one observation of the given parameter. | Units on a scale | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | Up to Week 52 | IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormal Vital Signs | Up to Week 52 | IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs) | Up to Week 52 | IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Extrapyramidal Symptoms Will be Assessed by Mean Change From Baseline on Abnormal Involuntary Movement Scale(AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Only Used in Japan) and Barnes Akathisia Rating Scale (BARS) | Baseline, Week 28, and Week 52 | IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. | Units on a scale | MEAN |
| PRIMARY | Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS) | Up to Week 52 | IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating | Up to Week 52 | IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Remained Stable at End of Treatment in Phase C | Up to Week 52 | IM Depot Maintenance Phase Efficacy Sample: All participants who entered the IM Depot Maintenance Phase, received at least 1 dose of aripiprazole IM depot, and had at least 1 post-baseline efficacy evaluation in the IM Depot Maintenance Phase. Number analyzed is the number of participants evaluated at the specified trial week. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Phase C: Open-label IM Depot Maintenance Phase | Participants with adverse events | 374 | Participants | |
| Number of Participants With Adverse Events | Phase C: Open-label IM Depot Maintenance Phase | Participants with TEAEs | 374 | Participants | |
| Number of Participants With Adverse Events | Phase C: Open-label IM Depot Maintenance Phase | Participants with serious TEAEs | 30 | Participants | |
| Number of Participants With Adverse Events | Phase C: Open-label IM Depot Maintenance Phase | Participants with severe TEAEs | 41 | Participants | |
| Number of Participants With Adverse Events | Phase C: Open-label IM Depot Maintenance Phase | Participants discontinued from IMP due to AEs | 47 | Participants | |
| Number of Participants With Adverse Events | Phase C: Open-label IM Depot Maintenance Phase | Participants discont. from IMP due to AEs or death | 48 | Participants | |
| Number of Participants With Adverse Events | Phase C: Open-label IM Depot Maintenance Phase | Deaths | 1 | Participants | |
| Injection Site Pain Measured by the Visual Analog Scale (VAS) | Phase C: Open-label IM Depot Maintenance Phase | 1ST Injection | 4.9 | Standard Deviation 10.7 | Units on a scale |
| Injection Site Pain Measured by the Visual Analog Scale (VAS) | Phase C: Open-label IM Depot Maintenance Phase | 2ND Injection | 4.1 | Standard Deviation 8.4 | Units on a scale |
| Injection Site Pain Measured by the Visual Analog Scale (VAS) | Phase C: Open-label IM Depot Maintenance Phase | 3RD Injection | 3.4 | Standard Deviation 7.5 | Units on a scale |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase C: Open-Label IM Depot Maintenance Phase | 464 | |
| Overall Study | COMPLETED | Phase C: Open-Label IM Depot Maintenance Phase | 291 | |
| Overall Study | NOT COMPLETED | Phase C: Open-Label IM Depot Maintenance Phase | 173 |
Source ClinicalTrials.gov
Adverse events35
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 | Injection site pain | General disorders | Phase C: Open-Label IM Depot Maintenance Phase | 34 | 464 | 50 |
| other | Nasopharyngitis | Infections and infestations | Phase C: Open-Label IM Depot Maintenance Phase | 56 | 464 | 87 |
| other | Upper respiratory tract infection | Infections and infestations | Phase C: Open-Label IM Depot Maintenance Phase | 24 | 464 | 27 |
| other | Weight increased | Investigations | Phase C: Open-Label IM Depot Maintenance Phase | 62 | 464 | 66 |
| other | Akathisia | Nervous system disorders | Phase C: Open-Label IM Depot Maintenance Phase | 68 | 464 | 79 |
| other | Headache | Nervous system disorders | Phase C: Open-Label IM Depot Maintenance Phase | 29 | 464 | 37 |
| other | Tremor | Nervous system disorders | Phase C: Open-Label IM Depot Maintenance Phase | 28 | 464 | 38 |
| other | Anxiety | Psychiatric disorders | Phase C: Open-Label IM Depot Maintenance Phase | 46 | 464 | 60 |
| other | Depression | Psychiatric disorders | Phase C: Open-Label IM Depot Maintenance Phase | 26 | 464 | 35 |
| other | Insomnia | Psychiatric disorders | Phase C: Open-Label IM Depot Maintenance Phase | 51 | 464 | 54 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase C: Open-Label IM Depot Maintenance Phase | 1 | 464 |
| Total, other adverse events | Phase C: Open-Label IM Depot Maintenance Phase | 367 | 464 |
| Total, serious adverse events | Phase C: Open-Label IM Depot Maintenance Phase | 30 | 464 |
Source ClinicalTrials.gov
Papers2
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
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