Trial · NCT01985581
Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD
NCT01985581, Phase 4, Completed, JPM van Stralen Medicine Professional; results first posted 2016-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD. Trials, record NCT01985581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01985581
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD
- NCT number
- NCT01985581
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 50 participants, actual
- Lead sponsor
- JPM van Stralen Medicine Professional
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Guanfacine extended release, Placebo, Stimulant therapy
- First posted
- 2013-11-15
- Last updated
- 2016-05-23
- Results first posted
- 2016-05-23
- Limitations and caveats
There was insufficient teacher data collected to interpret the results. Children appeared to struggle with the completion of the KINDL calling in to question the validity of the results of this questionnaire
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires | measured at baseline and end of each 12 week treament arm | The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function. |
| Secondary | Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire. | Measured at baseline and end of each 12 week treatment arm | The KINDL is a quality of life questionnaire of 24 items completed by the subject (KINDL-child). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the child |
| Secondary | Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV) | comparison from baseline to end of each 12 week treatment arm | The ADHD-RS-IV is completed by the Investigator familiar with the scale. It is an 18 item scale designed to reflect current symptomatology of ADHD based on the DSM-5 criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, with higher scores reflecting more severe symptoms |
| Secondary | Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm | Measured up to 30 weeks | To compare the number of subjects experiencing suicidal ideation, suicidal behaviour and self-injurious behaviour without suicidal intent as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and incident of Serious Adverse Events (SAEs) in each treatment arm |
| Secondary | Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire. | Measured at baseline and end of each 12 week treatment arm | The KINDL is a quality of life questionnaire of 24 items completed by the parent (KINDL-parent). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the parent. |
| Secondary | Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale | comparison from baseline to end of each 12 week treatment arm | The Clinical Global Impression- Severity scale is a scale of illness ranging from 1 (normal) to 7 (among the most severely ill patients). Subjects who felt normal, not at all ill or borderline mentally ill are considered improved. The outcome measure is reporting the percentage of participants showing improvement |
| Secondary | Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale | comparison from baseline to end of each 12 week treatment arm | CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Subjects who felt very much improved or much improved are considered improved.The outcome measure is reporting the percentage of participants showing improvement |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires | measured at baseline and end of each 12 week treament arm | ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline BRIEF questionnaire during either period 1 or period 2. | units on a scale | MEAN |
| SECONDARY | Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire. | Measured at baseline and end of each 12 week treatment arm | ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2. | units on a scale | MEAN |
| SECONDARY | Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV) | comparison from baseline to end of each 12 week treatment arm | ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2. | units on a scale | MEAN |
| SECONDARY | Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm | Measured up to 30 weeks | ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2. | subjects | NUMBER |
| SECONDARY | Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire. | Measured at baseline and end of each 12 week treatment arm | ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2. | units on a scale | MEAN |
| SECONDARY | Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale | comparison from baseline to end of each 12 week treatment arm | ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2. | percentage of subjects | NUMBER |
| SECONDARY | Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale | comparison from baseline to end of each 12 week treatment arm | ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires | Placebo and Stimulant | -5.3 | Standard Error 1.46 | units on a scale | |
| Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires | GXR and Stimulant | -6.9 | Standard Error 1.53 | units on a scale | |
| Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire. | Placebo and Stimulant | 0.8 | Standard Error 1.58 | units on a scale | |
| Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire. | GXR and Stimulant | 1.2 | Standard Error 1.62 | units on a scale | |
| Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV) | Placebo and Stimulant | -5.5 | Standard Error 1.63 | units on a scale | |
| Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV) | GXR and Stimulant | -11.1 | Standard Error 1.51 | units on a scale | |
| Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm | Stimulant & Placebo | 1 | subjects | ||
| Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm | Stimulant and Guanfancine Extended Release | 1 | subjects | ||
| Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire. | Placebo and Stimulant | 3.4 | Standard Error 1.46 | units on a scale | |
| Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire. | GXR and Stimulant | 1.4 | Standard Error 1.45 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Placebo First Then GXR | 25 | |
| First Intervention | STARTED | GXR First Then Placebo | 25 | |
| First Intervention | COMPLETED | Placebo First Then GXR | 22 | |
| First Intervention | COMPLETED | GXR First Then Placebo | 23 | |
| First Intervention | NOT COMPLETED | Placebo First Then GXR | 3 | |
| First Intervention | NOT COMPLETED | GXR First Then Placebo | 2 | |
| Second Intervention | STARTED | Placebo First Then GXR | 22 | |
| Second Intervention | STARTED | GXR First Then Placebo | 23 | |
| Second Intervention | COMPLETED | Placebo First Then GXR | 20 | |
| Second Intervention | COMPLETED | GXR First Then Placebo | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
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 | Headache | Nervous system disorders | Stimulant and GXR | 23 | 47 | |
| other | Headache | Nervous system disorders | Stimulant and PLB | 16 | 48 | |
| other | Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Stimulant and GXR | 12 | 47 | |
| other | Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Stimulant and PLB | 18 | 48 | |
| other | Abdominal Upper Pain | Gastrointestinal disorders | Stimulant and GXR | 14 | 47 | |
| other | Abdominal Upper Pain | Gastrointestinal disorders | Stimulant and PLB | 5 | 48 | |
| other | Insomnia | Nervous system disorders | Stimulant and GXR | 5 | 47 | |
| other | Insomnia | Nervous system disorders | Stimulant and PLB | 9 | 48 | |
| other | Vomiting | Gastrointestinal disorders | Stimulant and GXR | 5 | 47 | |
| other | Vomiting | Gastrointestinal disorders | Stimulant and PLB | 8 | 48 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stimulant and GXR | ||
| Total, all-cause mortality | Stimulant and PLB | ||
| Total, other adverse events | Stimulant and GXR | 41 | 47 |
| Total, other adverse events | Stimulant and PLB | 41 | 48 |
| Total, serious adverse events | Stimulant and GXR | 0 | 47 |
| Total, serious adverse events | Stimulant and PLB | 0 | 48 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Stimulant and GXR vs Stimulant and PLB: serious adverse events |
Source Trial comparisons
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/NCT01985581
GET https://conductscience.org/api/trials/v1/NCT01985581/events?page=2