Trial · NCT03659929
Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate
NCT03659929, Phase 3, Completed, Arbor Pharmaceuticals, Inc.; results first posted 2024-09-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate. Trials, record NCT03659929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03659929
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate
- NCT number
- NCT03659929
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 320 participants, actual
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Amphetamine Sulfate, Placebo
- First posted
- 2018-09-06
- Last updated
- 2024-09-03
- Results first posted
- 2024-09-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms | Week 5 (Visit 7) | Change from baseline in severity of Attention Deficit Hyperactivity (ADHD) symptoms, as measured by the adult ADHD Investigator Symptom Rating Scale (AISRS), with a minimum score of 0, and maximum score of 54. Higher scores indicate more severe symptoms, or a worse outcome. |
| Secondary | Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores | Up to 5 weeks | Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale (summed). The total score is the sum of the inattentive and hyperactive-impulsive subscales. Higher values represent more severe hyperactivity and/or inattentiveness. |
| Secondary | Change in Clinical Global Impression of Severity (CGI-S) Score From Baseline | Up to 5 weeks | CGI-Severity (CGI-S): The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. |
| Secondary | Change in Clinical Global Impression of Improvement (CGI-I) Score From Baseline | Up to 5 weeks | "Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment." |
| Secondary | Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score From Baseline | Up to 5 weeks | The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning (GEC) and 9 non-overlapping scales among 2 summary index scales (Metacognition Index \[MI\] and Behavioral Regulation Index \[BRI\]) that assess aspects of executive function and problems with self-regulation from the perspective of the individual. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 70 items yields the GEC raw score (range: 70-210), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score ≥ 65 is considered abnormally elevated). The post-baseline GEC T-score is converted to a change from baseline T-score. A lower change from baseline GEC T-score (\<0) represents a better outcome. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms | Week 5 (Visit 7) | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores | Up to 5 weeks | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Clinical Global Impression of Severity (CGI-S) Score From Baseline | Up to 5 weeks | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Clinical Global Impression of Improvement (CGI-I) Score From Baseline | Up to 5 weeks | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score From Baseline | Up to 5 weeks | T-Score | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms | Placebo | -11.1 | Standard Error 1.28 | score on a scale | |
| Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms | Amphetamine Sulfate (20 mg/Day) | -18.2 | Standard Error 1.28 | score on a scale | |
| Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms | Amphetamine Sulfate (40 mg/Day) | -18.1 | Standard Error 1.27 | score on a scale | |
| Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores | Placebo | Hyperactivity/Impulsivity Subscale | -5.2 | Standard Error 0.61 | score on a scale |
| Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores | Amphetamine Sulfate (20 mg/Day) | Hyperactivity/Impulsivity Subscale | -8.3 | Standard Error 0.61 | score on a scale |
| Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores | Amphetamine Sulfate (40 mg/Day) | Hyperactivity/Impulsivity Subscale | -8.0 | Standard Error 0.6 | score on a scale |
| Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores | Placebo | Inattentive Subscale | -5.9 | Standard Error 0.74 | score on a scale |
| Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores | Amphetamine Sulfate (20 mg/Day) | Inattentive Subscale | -9.9 | Standard Error 0.74 | score on a scale |
| Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores | Amphetamine Sulfate (40 mg/Day) | Inattentive Subscale | -10.0 | Standard Error 0.74 | score on a scale |
| Change in Clinical Global Impression of Severity (CGI-S) Score From Baseline | Placebo | Visit 3 (Week 1) | -0.5 | Standard Error 0.1 | score on a scale |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 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 | 106 | |
| Overall Study | STARTED | Amphetamine Sulfate (20 mg/Day) | 107 | |
| Overall Study | STARTED | Amphetamine Sulfate (40 mg/Day) | 107 | |
| Overall Study | COMPLETED | Placebo | 92 | |
| Overall Study | COMPLETED | Amphetamine Sulfate (20 mg/Day) | 87 | |
| Overall Study | COMPLETED | Amphetamine Sulfate (40 mg/Day) | 87 | |
| Overall Study | NOT COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Amphetamine Sulfate (20 mg/Day) | 20 | |
| Overall Study | NOT COMPLETED | Amphetamine Sulfate (40 mg/Day) | 20 |
Source ClinicalTrials.gov
Adverse events21
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 | Insomnia | Psychiatric disorders | Placebo | 4 | 106 | |
| other | Insomnia | Psychiatric disorders | Amphetamine Sulfate (20 mg/Day) | 9 | 107 | |
| other | Insomnia | Psychiatric disorders | Amphetamine Sulfate (40 mg/Day) | 10 | 107 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 4 | 106 | |
| other | Dry Mouth | Gastrointestinal disorders | Amphetamine Sulfate (20 mg/Day) | 6 | 107 | |
| other | Dry Mouth | Gastrointestinal disorders | Amphetamine Sulfate (40 mg/Day) | 12 | 107 | |
| other | Headache | Nervous system disorders | Placebo | 13 | 106 | |
| other | Headache | Nervous system disorders | Amphetamine Sulfate (20 mg/Day) | 14 | 107 | |
| other | Headache | Nervous system disorders | Amphetamine Sulfate (40 mg/Day) | 12 | 107 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 106 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 106 |
| Total, all-cause mortality | Amphetamine Sulfate (20 mg/Day) | 0 | 107 |
| Total, all-cause mortality | Amphetamine Sulfate (40 mg/Day) | 0 | 107 |
| Total, other adverse events | Placebo | 19 | 106 |
| Total, other adverse events | Amphetamine Sulfate (20 mg/Day) | 46 | 107 |
| Total, other adverse events | Amphetamine Sulfate (40 mg/Day) | 55 | 107 |
| Total, serious adverse events | Placebo | 0 | 106 |
| Total, serious adverse events | Amphetamine Sulfate (20 mg/Day) | 0 | 107 |
| Total, serious adverse events | Amphetamine Sulfate (40 mg/Day) | 0 | 107 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34428356 | DERIVED |
Source PubMed
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/NCT03659929
GET https://conductscience.org/api/trials/v1/NCT03659929/results?page=2