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Deramciclane in the treatment of generalized anxiety disorder: a placebo-controlled, double-blind, dose-finding study.
Eur Neuropsychopharmacol 2005; 15(6):617-23EN

Abstract

Deramciclane, a camphor derivative, is a novel anxiolytic agent with a unique mechanism of action. It acts as a potent and specific antagonist at serotonin 5-HT2A/2C receptors, and exhibits anxiolytic efficacy in animal models. The aim of this double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy, safety, and tolerability of a range of doses of deramciclane in patients with generalized anxiety disorder (GAD). Adult patients with a diagnosis of GAD (DSM-IV) and a Hamilton Anxiety Rating Scale (HAM-A) total score >or=18; a score >or=2 for the HAM-A items 'Anxious Mood' and 'Tension'; a score >or=4 on the Clinical Global Impression of Severity of Illness (CGI-S) Scale; and a score <or=20 on the Montgomery-Asberg Depression Rating Scale (MADRS) were enrolled in the study. Following a 1-2 week placebo run-in period, patients were randomized to receive deramciclane (10, 30, or 60 mg/day in two divided doses) or placebo for 8 weeks, followed by a 2-week placebo wash-out period. The primary efficacy measure was change in HAM-A score from baseline to week 8. Adverse events were monitored throughout the study. Withdrawal reactions were assessed at the end of the study (week 8) and during the placebo wash-out period using the Physician's Withdrawal Checklist (34 items). In the intent-to-treat population (n=208), both the deramciclane 30 mg/day and 60 mg/day doses provided clinically relevant improvements in HAM-A total score after 8 weeks of treatment, reaching statistical significance compared with placebo in the 60 mg/day dose group (p=0.024) and a clear trend in the 30 mg/day group (p=0.059). On the HAM-A psychic anxiety factor, significant improvements were seen in patients in the deramciclane 30 mg/day and 60 mg/day treatment groups compared with those in the placebo group (p<0.05). Adverse events were reported at a similar frequency across all four treatment groups; the most commonly reported adverse event was headache. No withdrawal reactions were observed on abrupt discontinuation of deramciclane. In conclusion, deramciclane 60 mg/day showed significant evidence of efficacy for the treatment of GAD in adult patients. The efficacy for the 30 mg/day dose was close to the larger dose although not significant in the primary analysis, and there was no significant evidence of efficacy for the 10 mg/day dose. Deramciclane was safe and well-tolerated up to the 60 mg/day dose over an 8-week period.

Authors+Show Affiliations

Department of Psychiatry, University of Helsinki, Box 320 (Lapinlahdentie), FIN-00180, HUCH, Helsinki, Finland. hannu.naukkarinen@hus.fiNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15949921

Citation

Naukkarinen, Hannu, et al. "Deramciclane in the Treatment of Generalized Anxiety Disorder: a Placebo-controlled, Double-blind, Dose-finding Study." European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology, vol. 15, no. 6, 2005, pp. 617-23.
Naukkarinen H, Raassina R, Penttinen J, et al. Deramciclane in the treatment of generalized anxiety disorder: a placebo-controlled, double-blind, dose-finding study. Eur Neuropsychopharmacol. 2005;15(6):617-23.
Naukkarinen, H., Raassina, R., Penttinen, J., Ahokas, A., Jokinen, R., Koponen, H., ... Rouru, J. (2005). Deramciclane in the treatment of generalized anxiety disorder: a placebo-controlled, double-blind, dose-finding study. European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology, 15(6), pp. 617-23.
Naukkarinen H, et al. Deramciclane in the Treatment of Generalized Anxiety Disorder: a Placebo-controlled, Double-blind, Dose-finding Study. Eur Neuropsychopharmacol. 2005;15(6):617-23. PubMed PMID: 15949921.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Deramciclane in the treatment of generalized anxiety disorder: a placebo-controlled, double-blind, dose-finding study. AU - Naukkarinen,Hannu, AU - Raassina,Roope, AU - Penttinen,Jukka, AU - Ahokas,Antti, AU - Jokinen,Riitta, AU - Koponen,Hannu, AU - Lepola,Ulla, AU - Kanerva,Harri, AU - Lehtonen,Leena, AU - Pohjalainen,Tiina, AU - Partanen,Auli, AU - Mäki-Ikola,Outi, AU - Rouru,Juha, AU - ,, Y1 - 2005/06/09/ PY - 2003/09/12/received PY - 2005/03/17/revised PY - 2005/03/17/accepted PY - 2005/6/14/pubmed PY - 2006/1/6/medline PY - 2005/6/14/entrez SP - 617 EP - 23 JF - European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology JO - Eur Neuropsychopharmacol VL - 15 IS - 6 N2 - Deramciclane, a camphor derivative, is a novel anxiolytic agent with a unique mechanism of action. It acts as a potent and specific antagonist at serotonin 5-HT2A/2C receptors, and exhibits anxiolytic efficacy in animal models. The aim of this double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy, safety, and tolerability of a range of doses of deramciclane in patients with generalized anxiety disorder (GAD). Adult patients with a diagnosis of GAD (DSM-IV) and a Hamilton Anxiety Rating Scale (HAM-A) total score >or=18; a score >or=2 for the HAM-A items 'Anxious Mood' and 'Tension'; a score >or=4 on the Clinical Global Impression of Severity of Illness (CGI-S) Scale; and a score <or=20 on the Montgomery-Asberg Depression Rating Scale (MADRS) were enrolled in the study. Following a 1-2 week placebo run-in period, patients were randomized to receive deramciclane (10, 30, or 60 mg/day in two divided doses) or placebo for 8 weeks, followed by a 2-week placebo wash-out period. The primary efficacy measure was change in HAM-A score from baseline to week 8. Adverse events were monitored throughout the study. Withdrawal reactions were assessed at the end of the study (week 8) and during the placebo wash-out period using the Physician's Withdrawal Checklist (34 items). In the intent-to-treat population (n=208), both the deramciclane 30 mg/day and 60 mg/day doses provided clinically relevant improvements in HAM-A total score after 8 weeks of treatment, reaching statistical significance compared with placebo in the 60 mg/day dose group (p=0.024) and a clear trend in the 30 mg/day group (p=0.059). On the HAM-A psychic anxiety factor, significant improvements were seen in patients in the deramciclane 30 mg/day and 60 mg/day treatment groups compared with those in the placebo group (p<0.05). Adverse events were reported at a similar frequency across all four treatment groups; the most commonly reported adverse event was headache. No withdrawal reactions were observed on abrupt discontinuation of deramciclane. In conclusion, deramciclane 60 mg/day showed significant evidence of efficacy for the treatment of GAD in adult patients. The efficacy for the 30 mg/day dose was close to the larger dose although not significant in the primary analysis, and there was no significant evidence of efficacy for the 10 mg/day dose. Deramciclane was safe and well-tolerated up to the 60 mg/day dose over an 8-week period. SN - 0924-977X UR - https://www.unboundmedicine.com/medline/citation/15949921/Deramciclane_in_the_treatment_of_generalized_anxiety_disorder:_a_placebo_controlled_double_blind_dose_finding_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0924-977X(05)00057-X DB - PRIME DP - Unbound Medicine ER -