Ramelteon for Complex Insomnia in Veterans With PTSD

Insomnia Clinical Trial

— DORMI  

Official title:

A Pilot, Randomized, Double-blind, Placebo Controlled, Trial of Ramelteon for CPAP Non-Adherent Veterans With PTSD and Complex Insomnia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03265951
• Other study ID #: RF-1070471
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obstructive sleep apnea is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure is the most effective therapy but adherence to treatment is suboptimal. The overarching theme of the proposal is to compare usual care to Ramelteon, in a randomized, clinical trial, investigating the effectiveness of physiological versus pharmacological intervention on sleep quality of life, insomnia severity and CPAP adherence.

Description:

Despite the overall improvement in PTSD symptomatology with CPAP therapy, adherence to CPAP is far worse in Veterans with PTSD (41%) compared to the general population with OSA (70%). Among the factors associated with CPAP non-adherence is the coexistence of insomnia. Complex insomnia defined as the coexistence of comorbid insomnia ans OSA is a frequent diagnosis in military personnel with combat exposure. Similar to prior reports of patients with OSA without PTSD, comorbid insomnia can create a barrier to CPAP therapy. Ramelteon (TAK-375), approved by the Food and Drug Administration for the treatment of insomnia with sleep onset abnormalities, is a neurohormone that functions as a melatonin receptor agonist targeting the MT1 and MT2 receptors located in the suprachiasmatic nucleus of the hypothalamus which regulates the circadian rhythm of the 24-hour sleep-wake cycle.The goal is to test the hypothesis that the administration of insomnia therapy-ramelteon- significantly improves treatment outcomes in Veterans with PTSD and complex insomnia compared with placebo.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age =18 years and =70 years old
• Diagnosis of PTSD as determined by the intake conducted through the PTSD Clinic or the Mental Health Clinic
• Documented obstructive sleep apnea by polysomnography (AHI=5 or more/hour)
• CPAP non adherence defined as less than 70% of nights with >4h CPAP use despite addressing modifiable barriers for CPAP adherence
• Psychotherapeutic treatment stable for at least 4 weeks prior to randomization
• Capable of giving informed consent

Exclusion Criteria:

• Medical:
• Acute or unstable chronic medical illness
• History of narcolepsy and/or cataplexy Use of any of these medications:

Fluvoxamine, fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin); fluoroquinolones including ciprofloxacin, levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), others; HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); nefazodone; rifampin

• Treatment for seizure disorders
• Pregnant or lactating
• History of clinically significant hepatic impairment
• History of hypersensitivity, intolerance, or contraindication to ramelteon
• Unwilling to try or use CPAP

Psychiatric/Behavioral:

• Diagnosis of current schizophrenia or schizoaffective disorder
• Diagnosis of a substance dependence/abuse disorder in the past year
• Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others
• Diagnosis of bipolar disorder
• Consumption of more than two alcoholic beverages per night
• Receiving behavioral or pharmacological treatment for insomnia

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Ramelteon
8 mg once daily administered within 30 minutes of bedtime

Other:
• Usual Care
education brochure about sleep hygiene

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center in Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	The VA Western New York Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index	Quality of life	12 weeks post randomization
Secondary	PCL-5	PTSD Checklist	12 weeks post randomization
Secondary	ISI	Insomnia Severity Index	12 weeks post randomization
Secondary	CPAP adherence	CPAP adherence	12 weeks post randomization