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

NCT01180855 | Unknown Phase 4 DMC

• 1 other identifier: 06-046R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Melatonin; Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• Sleep Onset Latency

  Daily assessment of sleep and daytime functioning (daily voice mail sleep diary and actigraphy) for 10 weeks: 2 weeks prior to and after treatment and during the 6 week treatment period. The primary sleep outcomes will be improvement in sleep onset latency (SOL) and total sleep time (TST).

  Baseline, Post treatment, 3 month follow up

Secondary Outcomes (1)

• Dim Light Melatonin Onset

  Baseline, post treatment

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo pills prepared by Takeda Pharmaceutical.

Drug: Placebo

Rozerem

ACTIVE COMPARATOR

Rozerem 8mg

Drug: Rozerem 8mg

Rozerem + Multi Component Behavior Therapy

ACTIVE COMPARATOR

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

Other: Rozerem 8mg in combination with Multi Component Behavior Therapy

Interventions

Placebo DRUG

Placebo pill nightly for 42 nights.

Placebo

Rozerem 8mg DRUG

Rozerem 8mg pill, nightly for 42 nights

Rozerem

Rozerem 8mg in combination with Multi Component Behavior Therapy OTHER

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

Rozerem + Multi Component Behavior Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

University of Arizona Sleep Research Laboratory

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Richard R Bootzin, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 12, 2010
• Study Start: August 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 12, 2010

Record last verified: 2010-08

Locations

US (1)