Safety Evaluation of Ritanserin—An Investigational Serotonin Antagonist
- 25 October 1986
- journal article
- clinical trial
- Published by SAGE Publications in Drug Intelligence & Clinical Pharmacy
- Vol. 20 (10), 770-775
- https://doi.org/10.1177/106002808602001006
Abstract
Ritanserin is an investigational serotonin-S2 receptor antagonist with activity in a variety of psychiatric disturbances characterized by dysthymia or anxiety. This investigation evaluates acute safety and tolerability of ritanserin in 12 healthy males. Ritanserin 10 mg, 20 mg, and placebo were administered as single doses in a randomized, double-blind, crossover fashion. Treatment effects on vital signs, laboratory tests, a mood evaluation test, electrocardiograms (ECGs), and reported adverse experiences were monitored. Plasma levels were determined at two hours postdose. Results indicated no clinically relevant effects on vital signs, laboratory tests, ECGs, or mood evaluations. Dose proportionality was demonstrated. The incidence of total adverse effects (primarily somnolence and fatigue) after single-dose administation was 25 percent for placebo, 75 percent for 10 mg, and 81.8 percent for 20 mg. There was a relationship between incidence of adverse effects and dose, but no general correlation between plasma levels and severity of adverse experiences. The results indicate that ritanserin is safe and tolerable following acute administration of 10 mg and 20 mg oral doses.Keywords
This publication has 4 references indexed in Scilit:
- The Influence of Ritanserin, a Serotonin Antagonist, in Anxiety Disorders: A Double-blind Placebo-controlled Study versus LorazepamPharmacopsychiatry, 1985
- Cardiovascular Effects of Ketanserin, A New Antiserotonergic Agent in the Treatment of Arterial HypertensionThe Journal of Clinical Pharmacology, 1985
- Pharmacology of Potent and Selective S2-Serotonergic AntagonistsJournal of Cardiovascular Pharmacology, 1985
- The SCL-90 and the MMPI: A Step in the Validation of a New Self-Report ScaleThe British Journal of Psychiatry, 1976