ADHD
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
Interventions
DRUGSPD503-AM
SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg
DRUGSPD503-PM
SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg
DRUGPlacebo
Placebo matched to Guanfacine Hydrochloride Extended Release
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks * Aged 6-17 years with a sub-optimal * Partial response to stimulants * Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) | Baseline and weekly up to 8 weeks | The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) |
| Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) | Baseline and weekly up to 8 weeks | The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30. |
| Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) | Baseline and weekly up to 8 weeks | The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30. |
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. |
| Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF | Baseline and weekly up to 8 weeks | The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms. |
| Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better. |
| Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Baseline and weekly up to 8 weeks | Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses. |
| Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF | Baseline and week 8 | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SPD503-AM + Psychostimulant Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | 150 |
| SPD503-PM + Psychostimulant Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks. | 152 |
| Placebo + Psychostimulant Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning. | 153 |
| Total | 455 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 6 | 1 |
| Overall Study | Exclusion criteria | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 3 | 2 | 5 |
| Overall Study | Lost to Follow-up | 9 | 3 | 5 |
| Overall Study | Protocol Violation | 8 | 6 | 3 |
| Overall Study | Randomized in error | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 8 | 11 |
Baseline characteristics
| Characteristic | SPD503-AM + Psychostimulant | SPD503-PM + Psychostimulant | Placebo + Psychostimulant | Total |
|---|---|---|---|---|
| Age, Continuous | 11.0 years STANDARD_DEVIATION 2.6 | 10.6 years STANDARD_DEVIATION 2.3 | 10.8 years STANDARD_DEVIATION 2.3 | 10.8 years STANDARD_DEVIATION 2.4 |
| Age, Customized 6-17 years | 150 Participants | 152 Participants | 153 Participants | 455 Participants |
| Region of Enrollment United States | 150 Participants | 152 Participants | 153 Participants | 455 Participants |
| Sex: Female, Male Female | 42 Participants | 46 Participants | 41 Participants | 129 Participants |
| Sex: Female, Male Male | 108 Participants | 106 Participants | 112 Participants | 326 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 116 / 150 | 116 / 152 | 97 / 153 |
| serious Total, serious adverse events | 1 / 150 | 2 / 152 | 0 / 153 |
Outcome results
Primary
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Time frame: Baseline and weekly up to 8 weeks
Population: Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD503-AM + Psychostimulant | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) | -20.4 Units on a scale | Standard Deviation 12.77 |
| SPD503-PM + Psychostimulant | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) | -21.0 Units on a scale | Standard Deviation 12.39 |
| Placebo + Psychostimulant | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) | -16.0 Units on a scale | Standard Deviation 11.77 |
Comparison: The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.p-value: 0.00295% CI: [-7.5, -1.4]ANCOVA
Comparison: The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.p-value: <0.00195% CI: [-8.3, -2.3]ANCOVA
Secondary
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: Baseline and weekly up to 8 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD503-AM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Borderline mentally ill | 19.5 Percent of participants |
| SPD503-AM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Markedly ill | 6.0 Percent of participants |
| SPD503-AM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Moderately ill | 16.1 Percent of participants |
| SPD503-AM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Normal, not at all ill | 22.8 Percent of participants |
| SPD503-AM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Most extremely ill | 0.0 Percent of participants |
| SPD503-AM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Severely ill | 1.3 Percent of participants |
| SPD503-AM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Mildly ill | 34.2 Percent of participants |
| SPD503-PM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Moderately ill | 16.2 Percent of participants |
| SPD503-PM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Normal, not at all ill | 25.0 Percent of participants |
| SPD503-PM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Borderline mentally ill | 26.4 Percent of participants |
| SPD503-PM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Mildly ill | 26.4 Percent of participants |
| SPD503-PM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Markedly ill | 5.4 Percent of participants |
| SPD503-PM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Severely ill | 0.7 Percent of participants |
| SPD503-PM + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Most extremely ill | 0.0 Percent of participants |
| Placebo + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Markedly ill | 9.2 Percent of participants |
| Placebo + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Borderline mentally ill | 17.8 Percent of participants |
| Placebo + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Most extremely ill | 0.0 Percent of participants |
| Placebo + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Severely ill | 2.0 Percent of participants |
| Placebo + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Moderately ill | 27.0 Percent of participants |
| Placebo + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Mildly ill | 28.9 Percent of participants |
| Placebo + Psychostimulant | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Normal, not at all ill | 15.1 Percent of participants |
Comparison: Not powered for secondary outcome measures.p-value: 0.013Cochran-Mantel-Haenszel
Comparison: Not powered for secondary outcome measures.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF
This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.
Time frame: Baseline and weekly up to 8 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD503-AM + Psychostimulant | Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF | -16.7 Units on a scale | Standard Deviation 13.87 |
| SPD503-PM + Psychostimulant | Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF | -16.7 Units on a scale | Standard Deviation 13.45 |
| Placebo + Psychostimulant | Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF | -11.5 Units on a scale | Standard Deviation 13.45 |
Comparison: Not powered for secondary outcome measures.p-value: <0.00195% CI: [-8, -2.2]ANCOVA
Comparison: Not powered for secondary outcome measures.p-value: 0.00295% CI: [-7.6, -1.7]ANCOVA
Secondary
Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)
The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.
Time frame: Baseline and weekly up to 8 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD503-AM + Psychostimulant | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) | -8.2 Units on a scale | Standard Deviation 7.79 |
| SPD503-PM + Psychostimulant | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) | -8.8 Units on a scale | Standard Deviation 7.21 |
| Placebo + Psychostimulant | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) | -6.0 Units on a scale | Standard Deviation 6.84 |
Comparison: Not powered for secondary outcome measures.p-value: 0.00295% CI: [-4, -0.9]ANCOVA
Comparison: Not powered for secondary outcome measures.p-value: <0.00195% CI: [-4.5, -1.5]ANCOVA
Secondary
Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)
The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.
Time frame: Baseline and weekly up to 8 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD503-AM + Psychostimulant | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) | -8.4 Units on a scale | Standard Deviation 7.27 |
| SPD503-PM + Psychostimulant | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) | -9.6 Units on a scale | Standard Deviation 7.68 |
| Placebo + Psychostimulant | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) | -6.9 Units on a scale | Standard Deviation 6.89 |
Comparison: Not powered for secondary outcome measures.p-value: 0.01995% CI: [-3.2, -0.3]ANCOVA
Comparison: Not powered for secondary outcome measures.p-value: <0.00195% CI: [-4, -1.1]ANCOVA
Secondary
Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF
The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
Time frame: Baseline and weekly up to 8 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD503-AM + Psychostimulant | Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF | -6.6 Units on a scale | Standard Deviation 6.97 |
| SPD503-PM + Psychostimulant | Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF | -6.3 Units on a scale | Standard Deviation 7.05 |
| Placebo + Psychostimulant | Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF | -4.2 Units on a scale | Standard Deviation 6.79 |
Comparison: Not powered for secondary outcome measures.p-value: 0.00195% CI: [-3.9, -0.9]ANCOVA
Comparison: Not powered for secondary outcome measures.p-value: 0.00395% CI: [-3.6, -0.7]ANCOVA
Secondary
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: Baseline and weekly up to 8 weeks
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD503-AM + Psychostimulant | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | 70.5 Percent of participants |
| SPD503-PM + Psychostimulant | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | 74.3 Percent of participants |
| Placebo + Psychostimulant | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | 57.9 Percent of participants |
Comparison: Not powered for secondary outcome measures.p-value: 0.024Cochran-Mantel-Haenszel
Comparison: Not powered for secondary outcome measures.p-value: 0.003Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF
Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: Baseline and week 8
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD503-AM + Psychostimulant | Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF | 69.8 Percent of participants |
| SPD503-PM + Psychostimulant | Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF | 67.7 Percent of participants |
| Placebo + Psychostimulant | Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF | 47.5 Percent of participants |
Comparison: Not powered for secondary outcome measures.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Not powered for secondary outcome measures.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Time frame: Baseline and weekly up to 8 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD503-AM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Good | 40.3 Percent of participants |
| SPD503-AM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Average | 26.8 Percent of participants |
| SPD503-AM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Very poor | 0.7 Percent of participants |
| SPD503-AM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Poor | 6.7 Percent of participants |
| SPD503-AM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Very good | 25.5 Percent of participants |
| SPD503-PM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Average | 29.7 Percent of participants |
| SPD503-PM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Very poor | 0.7 Percent of participants |
| SPD503-PM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Poor | 6.8 Percent of participants |
| SPD503-PM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Good | 41.2 Percent of participants |
| SPD503-PM + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Very good | 21.6 Percent of participants |
| Placebo + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Very good | 22.9 Percent of participants |
| Placebo + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Good | 40.5 Percent of participants |
| Placebo + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Very poor | 0.0 Percent of participants |
| Placebo + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Average | 33.3 Percent of participants |
| Placebo + Psychostimulant | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Poor | 3.3 Percent of participants |
Comparison: Not powered for secondary outcome measures.p-value: 0.971Cochran-Mantel-Haenszel
Comparison: Not powered for secondary outcome measures.p-value: 0.502Cochran-Mantel-Haenszel