Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia

NCT ID: NCT01180855

Last Updated: 2010-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-09-30

Brief Summary

The specific aims of the proposed study are to compare the sleep, daytime functioning, and circadian phase effects of ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin receptor agonist in humans alone and in combination with multi-component behavior therapy (MCBT) in patients with chronic insomnia.

Conditions

Insomnia

Study Design

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

Study Groups

Placebo

Placebo pills prepared by Takeda Pharmaceutical.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pill nightly for 42 nights.

Rozerem

Rozerem 8mg

Group Type: ACTIVE_COMPARATOR

Rozerem 8mg

Intervention Type: DRUG

Rozerem 8mg pill, nightly for 42 nights

Rozerem + Multi Component Behavior Therapy

Rozerem 8mg in combination with 4 small group sessions and 2 phone calls of Multi Component Behavior Therapy.

Group Type: ACTIVE_COMPARATOR

Rozerem 8mg in combination with Multi Component Behavior Therapy

Intervention Type: OTHER

Rozerem 8mg pill nightly for 42 nights with 4 sessions and 2 telephone calls of Multi Component Behavior Therapy.

Interventions

Placebo

Placebo pill nightly for 42 nights.

Intervention Type: DRUG

Rozerem 8mg

Rozerem 8mg pill, nightly for 42 nights

Intervention Type: DRUG

Rozerem 8mg in combination with Multi Component Behavior Therapy

Rozerem 8mg pill nightly for 42 nights with 4 sessions and 2 telephone calls of Multi Component Behavior Therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Medical and sleep/wake history. During the screening process, participants will receive a physical exam, urine and blood labs, and be interviewed about their medical and sleep/wake history and be asked questions about their present and past habitual sleep/wake schedule and nap times.

(b) Medication/drug/alcohol use. Participants must have no history of drug or alcohol abuse or dependency, consume no more than 2 alcoholic beverages a day or more than 14 per week, Participants must agree not to consume more than 2 beverages containing caffeine (caffeinated coffee, tea, colas) a day before 2 pm and none after 2 pm.

(c) Evaluation of Psychiatric/Psychological Suitability. Participants must demonstrate a full understanding of the requirements and demands of the study.

For inclusion/exclusion screening, participants will receive a sleep, medical, physical and psychiatric history examination, one-night of dim light melatonin onset evaluation in the sleep laboratory, one-night of polysomnography, and two weeks of baseline sleep assessment. If during the polysomnography assessment the participant had a respiratory disturbance index (RDI) of 15 or more, the participant would be considered to have met the exclusionary criterion for obstructive sleep apnea. A letter providing feedback of the all night polysomnography assessment will be sent to all participants.

Individuals with a history of psychiatric illnesses or psychiatric disorders will be excluded, such as but not limited to, alcoholism, drug dependency, mood disorders; schizophrenic disorders, anxiety disorders; personality disorders. Finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressants, neuroleptic medications or major tranquilizers will be excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not be exclusionary. Individuals who have been treated for insomnia within the past six months will be excluded.

Exclusion Criteria

Use of psychotropic, hypnotic medications known to affect sleep or contraindicated for use with ramelteon, or over-the-counter analgesics that contain caffeine, or herbal supplements, including products with herbs, melatonin, or St. John's Wort.

Substance use will be determined by self-report and urine toxicology during the screening visit. Women who are pregnant or are planning on becoming pregnant will be excluded from the study. Female participants will be given a pregnancy test during the screening process.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

University of Arizona

Principal Investigators

Richard R Bootzin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona Sleep Research Laboratory

Tucson, Arizona, United States

Countries

United States

Other Identifiers

06-046R

Identifier Type: -

Identifier Source: org_study_id