Phase 4
Completed N=32
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
ADHD With Sleep Onset Insomnia
Source: ClinicalTrials.gov NCT00622427 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Change in Baseline to 2 Weeks ADHD Rating Scale — 0; 0 percentage of change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline to 2 Weeks ADHD Rating Scale |
0; 0 | — |
| SECONDARY Change in Clinical Global Impression (CGI) |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00622427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.