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Melatonin Receptor Agonist

Rozerem + Multi Component Behavior Therapy for Insomnia (CBT Trial)

Phase 4
Waitlist Available
Led By Richard R Bootzin, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post treatment, 3 month follow up
Awards & highlights

CBT Trial 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.

Eligible Conditions
  • Insomnia

CBT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post treatment, 3 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post treatment, 3 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep Onset Latency
Secondary outcome measures
Dim Light Melatonin Onset

CBT Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Rozerem + Multi Component Behavior TherapyActive Control1 Intervention
Rozerem 8mg in combination with 4 small group sessions and 2 phone calls of Multi Component Behavior Therapy.
Group II: RozeremActive Control1 Intervention
Rozerem 8mg
Group III: PlaceboPlacebo Group1 Intervention
Placebo pills prepared by Takeda Pharmaceutical.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,241 Total Patients Enrolled
4 Trials studying Insomnia
198 Patients Enrolled for Insomnia
University of Colorado, DenverOTHER
1,732 Previous Clinical Trials
2,143,518 Total Patients Enrolled
5 Trials studying Insomnia
977 Patients Enrolled for Insomnia
Richard R Bootzin, PhDPrincipal InvestigatorUniversity of Arizona

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia
2007. "Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01180855.
All > Sle > Insomnia
~2 spots leftby Apr 2025
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