Therapeutic Effects of Tamsulosin in Nightmare Disorder: A
                    Randomized, Double Blind, Placebo-Controlled, Cross-Over, Pilot
                    Study

Negin Naderifar; Elnaz Roohi; Ali Sharifi; Nemat Jaafari; Farshad Hashemian

doi:10.1055/a-2226-3604

Drug Research, Inhaltsverzeichnis

Drug Res (Stuttg) 2024; 74(02): 53-59
DOI: 10.1055/a-2226-3604

Original Article

Therapeutic Effects of Tamsulosin in Nightmare Disorder: A Randomized, Double Blind, Placebo-Controlled, Cross-Over, Pilot Study

Negin Naderifar

¹Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran

,

Elnaz Roohi

²Department of Experimental Medicine, Faculty of Medicine, The University of British Columbia, Vancouver, Canada

,

Ali Sharifi

³Iranian Scientific Society of Clinical Hypnosis, Tehran, Iran

,

Nemat Jaafari

⁴Université de Poitiers, Unité de recherche clinique centre Hospitalier Henri Laborit, CeRCA CNRS7295, Poitiers, France

,

Farshad Hashemian

¹Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran

› Institutsangaben

Abstract

Nightmare disorder is associated with functional impairment, distress, and low quality of life; however, studies on pharmacotherapy of this debilitating disorder yielded mixed results. Prazosin, a non-selective α₁ blocker is reported to be effective in treatment of post-traumatic stress disorder-related nightmares. We aimed at investigating therapeutic effects of tamsulosin which has higher affinity for blocking α_1A and α_1D adrenoceptors in treatment of nightmare disorder. A randomized, double blind, cross-over, placebo-controlled pilot study was conducted. Patients were randomly assigned to receive Tamsulosin 0.4 mg once daily or placebo for period of four weeks. Following a 2-week wash-out period, they were crossed over to the other group and received drug or placebo for duration of 4 additional weeks. Nightmare frequency and intensity measurements were carried out using Disturbing Dreams and Nightmares Severity Index (DDNSI). Blood pressure measurements were also performed. According to per protocol analysis, mean DDNSI scores decreased following administration of tamsulosin and a statistical trend towards significance was reported (p=0.065, d=0.236). Results of intention to treat analysis showed significant difference in DDNSI scores after drug use (p=0.030, d=0.651). Additionally, DDNSI scores dropped significantly following placebo use. However, intention to treat analysis showed no statistically significant difference pre and post placebo period (0.064, d=0.040). Tamsulosin may be effective in treatment of nightmare disorder. However, further larger clinical trials are recommended to clarify the effectiveness of tamsulosin and α₁ subtypes in pharmacotherapy of nightmares.

Key words

tamsulosin - pharmacotherapy - nightmare disorder - adrenergic system - clinical trial

Volltext

Referenzen

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