Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00622427
• Collaborator: Takeda (Industry)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD With Sleep Onset Insomnia	Drug: Ramelteon; Drug: Placebo	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ramelteon then placebo 8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.	Drug: Ramelteon; 8 mg tablets every night for 2 weeks; Other Names: Rozerem
Experimental: 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.	Drug: Placebo; placebo tablets for every night for 2 weeks

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35205

Sponsors and Collaborators

• University of Alabama at Birmingham
• Takeda

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rachel Fargason, MD, Associate Professosr, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00622427
• Other Study ID Numbers: F071204001
• First Posted: Feb 25, 2008
• Last Update Posted: May 24, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

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.

Arm/Group Title	Ramelteon Then Placebo (8 mg)	Placebo Then Ramelteon (8 mg)
Arm/Group Description	QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep	QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
Period Title: Overall Study
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ramelteon Then Placebo (8 mg)	Placebo Then Ramelteon (8 mg)	Total
Arm/Group Description	QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep	QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep	Total of all reporting groups
Overall Participants	16	16	32
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	16 100%	32 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	9 56.3%	6 37.5%	15 46.9%
Male	7 43.8%	10 62.5%	17 53.1%
Region of Enrollment (participants) [Number]
United States	16 100%	16 100%	32 100%

Outcome Measures

1. Primary Outcome

Title	Change in Baseline to 2 Weeks ADHD Rating Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	QD for 14 days prior to sleep first	QD for 14 days prior to sleep first
Measure Participants	32	32
Mean (Standard Deviation) [percentage of change]	0 (0)	0 (0)

2. Secondary Outcome

Title	Change in Clinical Global Impression (CGI)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	QD for 14 days prior to sleep	QD for 14 days prior to sleep
Measure Participants	32	32
Mean (Standard Deviation) [percentage of change]	0 (0)	0 (0)

Adverse Events

Time Frame	Length of study--average of 6 weeks
Arm/Group Title	Ramelteon Then Placebo (8 mg)		Placebo Then Ramelteon (8 mg)
Arm/Group Description	QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep		QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
All Cause Mortality
	Ramelteon Then Placebo (8 mg)		Placebo Then Ramelteon (8 mg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ramelteon Then Placebo (8 mg)		Placebo Then Ramelteon (8 mg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Ramelteon Then Placebo (8 mg)		Placebo Then Ramelteon (8 mg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/16 (18.8%)		4/16 (25%)
Nervous system disorders
Drowsiness	2/16 (12.5%)	2	3/16 (18.8%)	3
Dizziness	0/16 (0%)	0	1/16 (6.3%)	1
Skin and subcutaneous tissue disorders
Hives	1/16 (6.3%)	1	0/16 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.