Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: ADHD With Sleep Onset Insomnia

Treatments: Drug: Ramelteon; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00622427

F071204001

Details and patient eligibility

About

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.

Full description

Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.

Enrollment: 32 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 2 patient groups

Ramelteon then placebo

Experimental group

Description:

8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.

Treatment:

Drug: Ramelteon

Placebo then Ramelteon

Experimental group

Description:

placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.

Treatment:

Drug: Placebo