Trial · NCT01074294
Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
NCT01074294, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2023-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder. Trials, record NCT01074294. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01074294
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
- NCT number
- NCT01074294
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 740 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- OPDC-34712, Placebo, Stimulant Therapy
- First posted
- 2010-02-24
- Last updated
- 2023-02-02
- Results first posted
- 2023-02-02
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline (End of Phase A) in the CAARS-O:SV ADHD Symptoms Total Score (18 Items) to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | The CAARS-O:SV is a 30 items scale with 3 subscales: Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Inattentive Symptoms (9 items), DSM- IV Hyperactive/Impulsive Symptoms (9 items), and DSM-IV ADHD Index (12 items). Total ADHD Symptoms Score (18 items) consisted of the combined score for the inattentive symptoms and hyperactive/impulsive symptoms subscales and is scored on a 4-point scale from 0 (not at all; never) to 3 (very much, very frequently) for a total score ranging from of 0 to 54, higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement. The Mixed model repeated measures (MMRM) model was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) in Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | WRAADDS is used to measure the severity of symptoms in adults with ADHD. This structured interview consists of 28 items in 7 psychopathologic domains, which were rated by a clinical expert on a 0 to 2-point Likert scale. The psychopathologic 7 domains are inattention (6 items), impulsivity (3 items), and hyperactivity (3 items), disorganization (5 items), temper (3 items), affective lability (4 items), and emotional over-reactivity (4 items). The scale rated individual items from 0 to 2 (0=not present, 1=mild, 2=clearly present) and summarized each of the 7 categories on a 0-to-4 scale (0=none, 1=mild, 2=moderate, 3=quite a bit, 4=very much). The WRAADDS total score is defined as sum of all 28 item sub scores (range 0 - 56), higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement. The analysis of covariance (ANCOVA) method was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) in Sleep Improvement Measured by Insomnia Severity Index (ISI) Total Score to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | The ISI is self-report instrument that has been validated specifically for measuring the perceived severity of insomnia. The scale was composed of a total of 7 items based on self-report questionnaire based on several indicators assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item was rated on a scale from 0 (none) to 4 (higher score indicating greater impairment/concern). A total score ranging from 0 to 28 was calculated from the sum of the individual item scores, higher scores indicate increased severity of insomnia. A negative change from Baseline indicates improvement. The MMRM model was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) in Sleep Improvement Measured by ISI for Item 2 Score (Difficulty Staying Asleep) to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | The ISI is self-report instrument that has been validated specifically for measuring the perceived severity of insomnia. The scale was composed of a total of 7 items based on self-report questionnaire based on several indicators assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item was rated on a scale from 0 (none) to 4 (higher score indicating greater impairment/concern). A total score ranging from 0 to 28 was calculated from the sum of the individual item scores, higher scores indicate increased severity of insomnia. A negative change from Baseline indicates improvement. The MMRM model was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) in the Spatial Working Memory (SWM) Between Errors 4-8 Boxes Test Score as Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB) to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | ADHD was measured with the CANTAB. SWM test was one of the tasks of CANTAB, SWM measured the ability to retain spatial information and to manipulate remembered items in working memory. This test was sensitive measure of executive dysfunction. Participants search for colored tokens hidden inside boxes on screen by touching them. The critical instruction was that once token has been found inside box, no token was hidden inside that box again, so participants must not return to box where a token was found. The key measurement of the SWM task is the SWM Between Errors 4-8 Boxes, which measured the total number of times a participant revisits a box in which a token has previously been found is measured for the 4, 6, and 8-box stages. Total scores ranged from 0-153. A lower score indicated better performance. The ANCOVA model was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) in CAARS-O:SV ADHD Symptoms Total Score (18 Items) to Each Time Point in Phase B Other Than Week 11 | Baseline [end of Phase A (Week 5)] to Weeks 6, 7, 8, 9 and 10 | The CAARS-O:SV is a 30 items scale with 3 subscales DSM-IV Inattentive Symptoms (9 items), DSM-IV Hyperactive/Impulsive Symptoms (9 items), and DSM-IV ADHD Index (12 items). Total ADHD Symptoms Score (18 items) consisted of the combined score for the inattentive symptoms and hyperactive/impulsive symptoms subscales and is scored on a 4-point scale from 0 (not at all; never) to 3 (very much, very frequently) for total score ranging from of 0 to 54, higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement. The MMRM model was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) in CAARS-O:SV Inattentive Symptoms Subscale Score (9 Items) to Each Time Point in Phase B | Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11 | The CAARS-O:SV is a 30 items scale with 3 subscales DSM-IV Inattentive Symptoms (9 items), DSM-IV Hyperactive/Impulsive Symptoms (9 items), and DSM-IV ADHD Index (12 items). The inattentive symptoms subscale (9 items) is scored on a 4-point scale from 0 (not at all; never) to 3 (very much, very frequently) with total score ranging from 0 to 27, higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement. The MMRM model was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) in CAARS-O:SV Hyperactive/Impulsive Symptoms Subscale Score (9 Items) to Each Time Point in Phase B | Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11 | The CAARS-O:SV is a 30 items scale with 3 subscales DSM-IV Inattentive Symptoms (9 items), DSM-IV Hyperactive/Impulsive Symptoms (9 items), and DSM-IV ADHD Index (12 items). The hyperactive/impulsive Symptoms Subscale is (9 items) scored on a 4-point scale from 0 (not at all; never) to 3 (very much, very frequently) with total score ranging from 0 to 27, higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement. The MMRM model was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) in CAARS-O:SV ADHD Index Score (12 Items) to Each Time Point in Phase B | Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11 | The CAARS-S:SV is a 30 items scale with 3 subscales inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items). The ADHD index score (12 items) is scored on a 4-point scale from 0 (not at all; never) to 3 (very much, very frequently) with total score ranging from 0 to 36, higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement. The MMRM model was used for analysis. |
| Secondary | Change From Baseline (End of Phase A) to Weeks 7 and 9 in ISI Total Score | Baseline [end of Phase A (Week 5)]; Weeks 7 and 9 | The ISI is self-report instrument that has been validated specifically for measuring the perceived severity of insomnia. The scale was composed of a total of 7 items based on self-report questionnaire based on several indicators assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item was rated on a scale from 0 (none) to 4 (higher score indicating greater impairment/concern). A total score ranging from 0 to 28 was calculated from the sum of the individual item scores, higher scores indicate increased severity of insomnia. A negative change from Baseline indicates improvement. The MMRM model was used for analysis. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline (End of Phase A) in the CAARS-O:SV ADHD Symptoms Total Score (18 Items) to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | Efficacy Sample consisted of participants in the Randomized Sample who had a Baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Overall number analyzed is the number of participants available for analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) in Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | Efficacy Sample consisted of participants in the Randomized Sample who had a Baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Overall number analyzed is the number of participants available for analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) in Sleep Improvement Measured by Insomnia Severity Index (ISI) Total Score to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | Efficacy Sample consisted of participants in the Randomized Sample who had a Baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Overall number analyzed is the number of participants available for analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) in Sleep Improvement Measured by ISI for Item 2 Score (Difficulty Staying Asleep) to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | Efficacy Sample consisted of participants in the Randomized Sample who had a baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Overall number analyzed is the number of participants available for analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) in the Spatial Working Memory (SWM) Between Errors 4-8 Boxes Test Score as Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB) to End of Phase B | Baseline [end of Phase A (Week 5)] to Week 11 | Efficacy Sample consisted of participants in the Randomized Sample who had a Baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Overall number analyzed is the number of participants available for analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) in CAARS-O:SV ADHD Symptoms Total Score (18 Items) to Each Time Point in Phase B Other Than Week 11 | Baseline [end of Phase A (Week 5)] to Weeks 6, 7, 8, 9 and 10 | Efficacy Sample consisted of participants in the Randomized Sample who had a Baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Number analyzed is the number of participants with data available for analyses at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) in CAARS-O:SV Inattentive Symptoms Subscale Score (9 Items) to Each Time Point in Phase B | Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11 | Efficacy Sample consisted of participants in the Randomized Sample who had a Baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Overall number analyzed is the number of participants available for analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) in CAARS-O:SV Hyperactive/Impulsive Symptoms Subscale Score (9 Items) to Each Time Point in Phase B | Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11 | Efficacy Sample consisted of participants in the Randomized Sample who had a Baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Number analyzed is the number of participants with data available for analyses at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) in CAARS-O:SV ADHD Index Score (12 Items) to Each Time Point in Phase B | Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11 | Efficacy Sample consisted of participants in the Randomized Sample who had a Baseline value for Phase B (ie, Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As pre-specified in the protocol and SAP the data is reported only for Phase B participants. Number analyzed is the number of participants with data available for analyses at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A) to Weeks 7 and 9 in ISI Total Score | Baseline [end of Phase A (Week 5)]; Weeks 7 and 9 | Efficacy Sample=participants in Randomized Sample who had Baseline value for Phase B (ie Week 5) and at least one post-randomization efficacy evaluation for CAARS-O:SV ADHD symptoms Total Score (18 items) in Phase B. As prespecified in protocol, SAP data is reported only for Phase B participants. Overall number of participants=number of participants with data available for analyses at Baseline. Number analyzed=number of participants with data available for analyses at given timepoint. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group232
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline (End of Phase A) in the CAARS-O:SV ADHD Symptoms Total Score (18 Items) to End of Phase B | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | -9.02 | Standard Error 0.77 | score on a scale | |
| Mean Change From Baseline (End of Phase A) in the CAARS-O:SV ADHD Symptoms Total Score (18 Items) to End of Phase B | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | -9.71 | Standard Error 1.06 | score on a scale | |
| Change From Baseline (End of Phase A) in Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score to End of Phase B | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | -3.93 | Standard Error 0.42 | score on a scale | |
| Change From Baseline (End of Phase A) in Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score to End of Phase B | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | -3.84 | Standard Error 0.56 | score on a scale | |
| Change From Baseline (End of Phase A) in Sleep Improvement Measured by Insomnia Severity Index (ISI) Total Score to End of Phase B | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | -1.05 | Standard Error 0.41 | score on a scale | |
| Change From Baseline (End of Phase A) in Sleep Improvement Measured by Insomnia Severity Index (ISI) Total Score to End of Phase B | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | -1.62 | Standard Error 0.56 | score on a scale | |
| Change From Baseline (End of Phase A) in Sleep Improvement Measured by ISI for Item 2 Score (Difficulty Staying Asleep) to End of Phase B | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | -0.04 | Standard Error 0.08 | score on a scale | |
| Change From Baseline (End of Phase A) in Sleep Improvement Measured by ISI for Item 2 Score (Difficulty Staying Asleep) to End of Phase B | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | -0.37 | Standard Error 0.10 | score on a scale | |
Change From Baseline (End of Phase A) in the Spatial Working Memory (SWM) Between Errors 4-8 Boxes Test Score as Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB) to End of Phase B | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 0.10 | Standard Error 0.67 | score on a scale | |
Change From Baseline (End of Phase A) in the Spatial Working Memory (SWM) Between Errors 4-8 Boxes Test Score as Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB) to End of Phase B | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | -0.31 | Standard Error 0.90 | score on a scale |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase A (Day 1 to Week 5) | STARTED | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 740 | |
| Phase A (Day 1 to Week 5) | STARTED | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 0 | |
| Phase A (Day 1 to Week 5) | STARTED | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | 0 | |
| Phase A (Day 1 to Week 5) | STARTED | Phase A+ (Single-blind Phase A Responders and Non-responders): Placebo + Stimulant | 0 | |
| Phase A (Day 1 to Week 5) | Analyzed for Safety | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 733 | |
| Phase A (Day 1 to Week 5) | Analyzed for Safety | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 0 | |
| Phase A (Day 1 to Week 5) | Analyzed for Safety | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | 0 | |
| Phase A (Day 1 to Week 5) | Analyzed for Safety | Phase A+ (Single-blind Phase A Responders and Non-responders): Placebo + Stimulant | 0 | |
| Phase A (Day 1 to Week 5) | COMPLETED | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 574 | |
| Phase A (Day 1 to Week 5) | COMPLETED | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events60
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 | Diarrhoea | Gastrointestinal disorders | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 0 | 733 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 3 | 155 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | 5 | 80 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase A+ (Single-blind Phase A Responders and Non-responders): Placebo + Stimulant | 0 | 339 | |
| other | Upper respiratory tract infection | Infections and infestations | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 0 | 733 | |
| other | Upper respiratory tract infection | Infections and infestations | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 5 | 155 | |
| other | Upper respiratory tract infection | Infections and infestations | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | 5 | 80 | |
| other | Upper respiratory tract infection | Infections and infestations | Phase A+ (Single-blind Phase A Responders and Non-responders): Placebo + Stimulant | 0 | 339 | |
| other | Weight decreased | Investigations | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 47 | 733 | |
| other | Weight decreased | Investigations | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 5 | 155 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 0 | 733 |
| Total, all-cause mortality | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 0 | 155 |
| Total, all-cause mortality | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | 0 | 80 |
| Total, all-cause mortality | Phase A+ (Single-blind Phase A Responders and Non-responders): Placebo + Stimulant | 0 | 339 |
| Total, other adverse events | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 440 | 733 |
| Total, other adverse events | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 32 | 155 |
| Total, other adverse events | Phase B (Double-blind Randomization Phase): Placebo + Stimulant | 25 | 80 |
| Total, other adverse events | Phase A+ (Single-blind Phase A Responders and Non-responders): Placebo + Stimulant | 17 | 339 |
| Total, serious adverse events | Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | 0 | 733 |
| Total, serious adverse events | Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | 0 | 155 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Rapid Visual Information Processing | Secondary outcome | ConductCognition |
| Stop-Signal Task | Secondary outcome | ConductCognition |
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/NCT01074294
GET https://conductscience.org/api/trials/v1/NCT01074294/registered?page=2