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

Insomnia Clinical Trial

— CBT  

Official title:

Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia: A Randomized, Double-Blind, Placebo Controlled Study (Investigator Initiated Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01180855
• Other study ID #: 06-046R
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 9, 2010
• Last updated: August 11, 2010
• Start date: August 2007
• Est. completion date: September 2010

Study information

• Verified date: August 2010
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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:

• Exclusion criteria include diagnosis or treatment of other sleep disorders such as obstructive sleep apnea, narcolepsy, sleep walking, and periodic limb movement disorders. Participants with a history of night work in the preceding 6 months or transmeridian travel (across >3 time zones) in the last 1 month prior to the study will be excluded.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• Placebo
Placebo pill nightly for 42 nights.
• Rozerem 8mg
Rozerem 8mg pill, nightly for 42 nights

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Arizona Sleep Research Laboratory	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Dim Light Melatonin Onset	Assessment of circadian melatonin phase 2 weeks prior to and 2 weeks after treatment(dim light melatonin onset—DLMO, 2 weeks prior to treatment and 2 weeks post treatment assessment of quality of life (SF-36) and sleep quality (Pittsburgh Sleep Quality Index—PSQI), 2 weeks prior to treatment and 2 weeks post treatmemnt daily assessment of daytime functioning.	Baseline, post treatment	No