Abstract | PURPOSE: METHOD: A randomised, crossover, triple-blind, placebo-controlled clinical trial, with two three-month periods of treatment starting with either agomelatine or placebo and a washout period of two weeks. Ambulatory circadian monitoring (24 hours/7 days) evaluated total sleep time (TST) as the primary outcome variable. RESULTS: Participants (N=23; 35±12 years old; 83% male) had a median of three (interquartile range (IQR) 1-4) co-morbidities and were taking a median of five (IQR 2-7) prescribed drugs. Before agomelatine or placebo treatment, all subjects presented with insomnia symptoms, including sleep latency (100% abnormal, 55±23 minutes) or TST (55% abnormal, 449±177 minutes), and 66% had circadian rhythm sleep-wake abnormalities with rhythm phase advancements according to the M5 sleep phase marker values. During the three-month agomelatine treatment, night TST significantly increased by a mean of 83 minutes (16% abnormal, 532±121 minutes), together with a phase correction (M5 1:45±2:28 hours vs. 3:15±2:20 hours), improving sleep stability in wrist temperature rhythm (0.43±0.29 vs. 0.52±0.18 AU). Adverse events were mild and transient. CONCLUSIONS:
Agomelatine was effective and well tolerated for treating insomnia and circadian rhythm sleep problems present in adults with ASD and ID.
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Authors | Pura Ballester, María José Martínez, María-Del-Mar Inda, Auxiliadora Javaloyes, Amanda L Richdale, Javier Muriel, César Belda, Natalia Toral, Domingo Morales, Eduardo Fernández, Ana M Peiró |
Journal | Journal of psychopharmacology (Oxford, England)
(J Psychopharmacol)
Vol. 33
Issue 11
Pg. 1395-1406
(11 2019)
ISSN: 1461-7285 [Electronic] United States |
PMID | 31423939
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Acetamides
- Hypnotics and Sedatives
- agomelatine
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Topics |
- Acetamides
(administration & dosage, adverse effects)
- Adult
- Autism Spectrum Disorder
(complications, drug therapy)
- Circadian Rhythm
- Cross-Over Studies
- Double-Blind Method
- Female
- Humans
- Hypnotics and Sedatives
(administration & dosage, adverse effects)
- Intellectual Disability
(complications, drug therapy)
- Male
- Middle Aged
- Sleep Wake Disorders
(drug therapy, etiology)
- Time Factors
- Young Adult
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