Ramelteon for Complex Insomnia in Veterans With PTSD

NCT ID: NCT03265951

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-06-30

Brief 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.

Detailed 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.

Conditions

Insomnia

Study Design

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

Study Groups

Ramelteon

Ramelteon 8 mg po at bedtime

Group Type: ACTIVE_COMPARATOR

Ramelteon

Intervention Type: DRUG

8 mg once daily administered within 30 minutes of bedtime

Usual care

education brochure about sleep hygiene

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: OTHER

education brochure about sleep hygiene

Interventions

Ramelteon

8 mg once daily administered within 30 minutes of bedtime

Intervention Type: DRUG

Usual Care

education brochure about sleep hygiene

Intervention Type: OTHER

Other Intervention Names

Rozerem

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The VA Western New York Healthcare System

FED

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Ali El Solh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali El Solh, MD

Role: PRINCIPAL_INVESTIGATOR

The VA Western New York

Locations

Veterans Affairs Medical Center in Buffalo

Buffalo, New York, United States

Countries

United States

Other Identifiers

RF-1070471

Identifier Type: -

Identifier Source: org_study_id