Ramelteon for Complex Insomnia in Veterans With PTSD
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/17/2018 |
| Start Date: | January 1, 2018 |
| End Date: | June 30, 2020 |
| Contact: | Ali El Solh, MD |
| Email: | solh@buffalo.edu |
| Phone: | 7169979336 |
A Pilot, Randomized, Double-blind, Placebo Controlled, Trial of Ramelteon for CPAP Non-Adherent Veterans With PTSD and Complex Insomnia
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.
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.
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.
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.
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
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