Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

NCT ID: NCT00622427

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-12-31

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.

Conditions

ADHD With Sleep Onset Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ramelteon then placebo

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

Group Type: EXPERIMENTAL

Ramelteon

Intervention Type: DRUG

8 mg tablets every night for 2 weeks

Placebo then Ramelteon

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

placebo tablets for every night for 2 weeks

Interventions

Ramelteon

8 mg tablets every night for 2 weeks

Intervention Type: DRUG

Placebo

placebo tablets for every night for 2 weeks

Intervention Type: DRUG

Other Intervention Names

Rozerem

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Rachel Fargason, MD

Associate Professosr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F071204001

Identifier Type: -

Identifier Source: org_study_id