Footnotes This work was supported by The Danish Research Council, University of Copenhagen and the Lundbeck Foundation. Ulla Knorr was supported by a fellowship from the Center for Pharmacogenomics, University of Copenhagen. The trial was fully investigator initiated and controlled to secure unbiased assessment of the effect of escitalopram on healthy first-degree relatives of Fasudil manufacturer patients with depression. AG, PW, CG, JW and UG declare to have no competing interests. UK has been a speaker for Servier. MV has been a speaker for Eli Lilly, Wyeth, Jannsen-Cilag, AstraZeneca and Pfizer. LVK has been a consultant for Inhibitors,research,lifescience,medical Bristol-Myers Squibb, Eli Lilly, Lundbeck, AstraZeneca,
Servier and Jannsen-Cilag. The AGENDA trial has received nonrestricted grants Inhibitors,research,lifescience,medical from not-for-profit and for-profit organizations.
Antipsychotic nonneurological side effects, such as sexual dysfunction, can adversely affect the quality of patients’ relationships, their treatment adherence and their quality of life [Goff and Shader, 2003]. Sexual side effects of treatment are distressing to patients and can be experienced as worse than the symptoms of schizophrenia itself [Finn et al. 1990; Lambert et al. 2004]. Up to two thirds of treated patients report problems with sexual function in Inhibitors,research,lifescience,medical the previous month, although sexual side effects can be both underreported by patients and underdetected
by clinicians [Karagianis et al. 2009; Yusufi et al. 2007]. This, together with the variety of assessment tools being Inhibitors,research,lifescience,medical used to measure sexual side effects in treated schizophrenia, means that review and synthesis of the existing literature is not straightforward. We set out to validate the sexual side-effects section of the ANNSERS (Antipsychotic Non-Neurological Side Effects Rating Scale) by examining scores in a subgroup of participants in a large UK trial. Methods The CUtLASS trials The UK CUtLASS study Inhibitors,research,lifescience,medical (Cost Utility of the
Latest Antipsychotics in Severe Schizophrenia) [Jones et al. 2006; Lewis et al. 2006] comprised two multicentre randomized controlled trials. CUtLASS 1 [Jones et al. 2006] compared first-generation antipsychotic (FGA) with (nonclozapine) second-generation antipsychotic (SGA) drugs in patients having Methisazone a change in their treatment because of poor response or side effects. CUtLASS 2 [Lewis et al. 2006] compared SGAs with clozapine in patients with treatment-resistant schizophrenia. Three follow-up assessments, which were blind to treatment allocation, took place over the course of 1 year. Participants Participants (N=26) were patients aged 18–65 years with DSM-IV schizophrenia and related (schizoaffective or delusional) disorders. Measures Measures used were ANNSERS version 1 (ANNSERSv1) and the Derogatis Interview for Sexual Functioning (self report version; DISF-SR) [Derogatis, 1997]. The ANNSERS is a new scale to assess the side effects associated with both FGA and SGA drugs, and has good inter-rater reliability [Ohlsen et al. 2008; Yusufi et al. 2005].