Trial · NCT00714688
A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder
NCT00714688, Phase 3, Completed, Janssen-Cilag International NV; results first posted 2010-04-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder. Trials, record NCT00714688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00714688
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder
- NCT number
- NCT00714688
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 279 participants, actual
- Lead sponsor
- Janssen-Cilag International NV
- Conditions
- Attention Deficit/ Hyperactivity Disorder
- Interventions
- prolonged release (PR) OROS methylphenidate 54 mg, prolonged release (PR) OROS methylphenidate 72 mg, Placebo
- First posted
- 2008-07-14
- Last updated
- 2014-05-08
- Results first posted
- 2010-04-21
- Limitations and caveats
Study was not designed to statistically compare the 54 mg with the 72 mg dose. Study medication was not titrated to the assigned dose as in clinical practice. This could have differentially affected treatment emergence of AEs and patient retention.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | from baseline to 13 weeks | The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed. |
| Secondary | Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment | from baseline to13 weeks | The CGI-S rating scale is used to rate the severity of a subject's illness on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe illness). The change in CGI-S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment) |
| Secondary | Clinical Global Impression-Change (CGI-C) | 13 weeks | The CGI-C rating scale is used to rate the change in severity of the subject's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). |
| Secondary | Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score | from baseline to 13 weeks | The CAARS-S:S is a 26-item self-report scale that measures symptoms based on the DSM-IV criteria for ADHD. Respondents were asked to rate items pertaining to their behavior/problems using the following 4-point scale (from 0 = Not at all, never; to 3 = Very much, very frequently). The CAARS-S:S total score range is from 0 (best) to 78 (worse). The change in CAARS-S:S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment) |
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 | Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | from baseline to 13 weeks | The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set. | units on a scale | MEAN |
| SECONDARY | Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment | from baseline to13 weeks | The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set. | units on a scale | MEDIAN |
| SECONDARY | Clinical Global Impression-Change (CGI-C) | 13 weeks | The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.It excludes patients for which either a baseline or end of treatment value was missing. | units on a scale | MEDIAN |
| SECONDARY | Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score | from baseline to 13 weeks | The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set. It excludes patients for which a baseline value was missing. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | Placebo | Baseline | 36.5 | Standard Deviation 6.05 | units on a scale |
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | 54 mg PR OROS MPH | Baseline | 35.6 | Standard Deviation 6.75 | units on a scale |
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | 72 mg PR OROS MPH | Baseline | 37.3 | Standard Deviation 6.35 | units on a scale |
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | Placebo | Endpoint | 26.1 | Standard Deviation 10.59 | units on a scale |
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | 54 mg PR OROS MPH | Endpoint | 23.0 | Standard Deviation 11.07 | units on a scale |
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | 72 mg PR OROS MPH | Endpoint | 21.6 | Standard Deviation 10.21 | units on a scale |
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | Placebo | Change at Endpoint | -10.4 | Standard Deviation 11.03 | units on a scale |
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | 54 mg PR OROS MPH | Change at Endpoint | -12.5 | Standard Deviation 10.38 | units on a scale |
| Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) | 72 mg PR OROS MPH | Change at Endpoint | -15.7 | Standard Deviation 10.80 | units on a scale |
| Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment | Placebo | 0.0 | Full Range -6 to 1 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 97 | |
| Overall Study | STARTED | 54 mg PR OROS MPH | 90 | |
| Overall Study | STARTED | 72 mg PR OROS MPH | 92 | |
| Overall Study | COMPLETED | Placebo | 68 | |
| Overall Study | COMPLETED | 54 mg PR OROS MPH | 55 | |
| Overall Study | COMPLETED | 72 mg PR OROS MPH | 55 | |
| Overall Study | NOT COMPLETED | Placebo | 29 | |
| Overall Study | NOT COMPLETED | 54 mg PR OROS MPH | 35 | |
| Overall Study | NOT COMPLETED | 72 mg PR OROS MPH | 37 |
Source ClinicalTrials.gov
Adverse events93
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 | Decreased Appetite | Metabolism and nutrition disorders | Placebo | 5 | 97 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | 54 mg PR OROS MPH | 17 | 89 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | 72 mg PR OROS MPH | 26 | 92 | |
| other | Anorexia | Metabolism and nutrition disorders | Placebo | 4 | 97 | |
| other | Anorexia | Metabolism and nutrition disorders | 54 mg PR OROS MPH | 6 | 89 | |
| other | Anorexia | Metabolism and nutrition disorders | 72 mg PR OROS MPH | 12 | 92 | |
| other | Insomnia | Psychiatric disorders | Placebo | 11 | 97 | |
| other | Insomnia | Psychiatric disorders | 54 mg PR OROS MPH | 13 | 89 | |
| other | Insomnia | Psychiatric disorders | 72 mg PR OROS MPH | 15 | 92 | |
| other | Initial Insomnia | Psychiatric disorders | Placebo | 2 | 97 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 54 mg PR OROS MPH | ||
| Total, all-cause mortality | 72 mg PR OROS MPH | ||
| Total, other adverse events | Placebo | 56 | 97 |
| Total, other adverse events | 54 mg PR OROS MPH | 72 | 89 |
| Total, other adverse events | 72 mg PR OROS MPH | 79 | 92 |
| Total, serious adverse events | Placebo | 2 | 97 |
| Total, serious adverse events | 54 mg PR OROS MPH | 3 | 89 |
| Total, serious adverse events | 72 mg PR OROS MPH | 2 | 92 |
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/NCT00714688
GET https://conductscience.org/api/trials/v1/NCT00714688/events?page=2