ADHD With Sleep Onset Insomnia
Conditions
Brief summary
Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.
Detailed description
Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.
Interventions
DRUGRamelteon
8 mg tablets every night for 2 weeks
DRUGPlacebo
placebo tablets for every night for 2 weeks
Sponsors
Takeda
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ADHD and insomnia- * 19-65 years of age * In good general health * Negative pregnancy test
Exclusion criteria
* Current primary psychiatric diagnosis other than ADHD * Positive urine drug screen for any sedative hypnotic or drugs of abuse * Unstable medical condition * HIV positive * Seizure disorder * Known hypersensitivity to Ramelteon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline to 2 Weeks ADHD Rating Scale | day 1 to day 14 of study drug | It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Global Impression (CGI) | day 1 to day 14 of study drug | The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug. |
Countries
United States
Participant flow
Recruitment details
Subjects were screened by medical and psychiatric history after responding to solicitation with advertisements in local newspapers and from existing clinic populations.
Participants by arm
| Arm | Count |
|---|---|
| Ramelteon Then Placebo (8 mg) QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep | 16 |
| Placebo Then Ramelteon (8 mg) QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Ramelteon Then Placebo (8 mg) | Placebo Then Ramelteon (8 mg) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 16 | 4 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Change in Baseline to 2 Weeks ADHD Rating Scale
It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.
Time frame: day 1 to day 14 of study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon | Change in Baseline to 2 Weeks ADHD Rating Scale | 0 percentage of change | Standard Deviation 0 |
| Placebo | Change in Baseline to 2 Weeks ADHD Rating Scale | 0 percentage of change | Standard Deviation 0 |
Secondary
Change in Clinical Global Impression (CGI)
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.
Time frame: day 1 to day 14 of study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon | Change in Clinical Global Impression (CGI) | 0 percentage of change | Standard Deviation 0 |
| Placebo | Change in Clinical Global Impression (CGI) | 0 percentage of change | Standard Deviation 0 |