"Escitalopram Helps Prevents Relapses of Obsessive-Compulsive Disorder: Presented at ECNP"
By Chris Berrie
PARIS, FRANCE -- September 18, 2006 -- Escitalopram, a highly selective serotonin reuptake inhibitor (SSRI), significantly prevents relapses compared with placebo in treatment-responsive patients with obsessive-compulsive disorder (OCD), according to a 24-week, randomised, double-blind, relapse-prevention study.
The study was presented here on September 17[th at the 19th Congress of the European College of Neuropsychopharmacology (ECNP).
The presenter was principal investigator Naomi A. Fineberg, MD, visiting professor and consultant psychiatrist, Postgraduate Medical School, University of Hertfordshire, Hatfield, and director, UK National Treatment Service for Resistant OCD, department of psychiatry, Queen Elizabeth II Hospital, Welwyn Garden City, United Kingdom.
While various SSRIs are generally effective for acute treatment of OCD, Dr. Fineberg said, "Obsessive-compulsive disorder is a chronic illness that affects a large proportion of the general population, and so we need to know that treatments are not only effective in the short term, but also in the long term and for preventing relapse."
Following an initial acute, 16-week, open-label study of escitalopram 10/20 mg flexible dosing in patients with OCD, responders were carried through into randomisation for the relapse-prevention stage.
For their study, Dr. Fineberg and colleagues classified treatment response according to the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), as a 25% or greater reduction in the Y-BOCS.
The prospectively defined primary analysis of efficacy was time to relapse from the start of the double-blind treatment, with relapse defined as an increase in the Y-BOCS total score of 5 points or greater, or a lack of efficacy as judged by the investigator.
Of the 468 patients who entered the initial acute treatment trial, 374 completed, and the 320 responders to escitalopram entered randomisation to placebo (n = 157) or escitalopram (n = 163) 10/20 mg fixed dose. Of these, 62 and 111, respectively, completed the 24-week, relapse-prevention stage.
All efficacy analyses at this stage were based on the intention-to-treat (ITT) population. To exclude potentially confounding effects, the influence of discontinuation symptoms on the primary analysis was investigated by censoring relapses occurring during the first 7 and 14 days after randomisation.
At study entry, the patient population was about 50% male and had a mean age of about 36 years. Patients had stable OCD according to criteria from the Diagnostic and Statistical Manual of Mental Disorders, Revision IV and had been symptomatic for a mean of 5 years (range, 1-52 years).
With a mean Y-BOCS score of 26, these patients had moderate to severe OCD. Their mean baseline National Institute of Health Obsessive-Compulsive Scale (NIMH-OCS) total score of 9 also defined their clinical-obsessive behaviour, and they were a markedly ill population (Clinical Global Impression of Severity [CGI-S], 5) with low levels of comorbid depression (Montgomery-Ashberg Depression Rating Scale [MADRS] total score, 10).
In the randomisation phase, there were no significant differences in the demographic and clinical parameters between the 2 treatment groups.
The primary efficacy analysis demonstrated a significantly superior effect over placebo of escitalopram for time to relapse of OCD (P < .001). The proportion of patients who relapsed was significantly higher in the placebo group than in the escitalopram group (52% vs 24%, respectively; P < .001).
Cox proportional analysis indicated a significant hazard ratio of 2.74 (P < .001) towards benefit from escitalopram. This was significant from week 4 (P < .05), and was maintained throughout the 24 weeks of this relapse-prevention trial.
Following 94 withdrawals from the original 468 patients with OCD, a further 8.9% (14 patients) and 7.9% (13) withdrew from this relapse-prevention stage in the placebo and escitalopram groups, respectively.
While 70.5% of the acute-phase patients had treatment-emergent adverse events (AEs), this was reduced for both placebo and escitalopram groups in the relapse-prevention stage both during the first 2 weeks from randomisation (29.8% vs 14.1%, respectively) and from week 2 to 24 (31.8% vs 39.3%). The former of these was significantly lower in the escitalopram group (P < .001), with this difference arising more specifically from escitalopram-associated reductions in nausea (5.7% vs 0.6%, P < .01) and dizziness (15.9% vs 0.6%). However, these significant differences disappeared from week 2 to 24. There were no clinically relevant changes within or differences between the vital signs of these 2 treatment groups.
Dr. Fineberg indicated that patients that remained on escitalopram remained well for longer than did those who were switched to, double-blind, to placebo. This, he noted, indicated that patients who remain on escitalopram have significantly improved outcomes and prevent relapses for longer durations of time.
Therefore, while she noted that the evidence for the benefits of escitalopram in this study is particularly persuasive, the take-home message should be that whichever of the SSRIs might be used to treat patients with OCD, "Once you have found a treatment that works, you should stay on it."
This study was supported by Lundbech A/S.
[Presentation title: Escitalopram in Relapse Prevention in Patients With Obsessive-Compulsive Disorder (OCD). Abstract P.2.a.017]
|
