Obsessive Compulsive Disorder (OCD) is increasingly recognised to be relatively common and responsive to some drug treatments (serotonin reuptake inhibitors). Clinical studies utilising recognised diagnostic criteria have identified some relevant negative prognostic factors: early age at disease onset, severe baseline disease, and failure of previous drug treatments all of which reduce the apparent success rates of SRI drugs. Furthermore, patients with comorbid tics seem to respond best to a combination of SRI activity and dopamine blockade. Short term efficacy studies are best performed with a parallel group design and a duration of around 3 months. Long term efficacy studies should probably use the relapse prevention design, with open label responders randomised to double blind continuation or placebo. Does finding has not been properly explored, and any one fixed dose will only be optimal for some patients. Efficacy can be reliably measured using the YBOCs, NIMH-OC and CGI rating scales.

Subjects with anxiety disorders display substantial disabilities in health-related quality of life. The Sheehan Disability Scale (SDS) and SF-36 Questionnaire (SF-36) have been administered to subjects with anxiety disorders participating in psychopharmacology clinical trials and observational studies to evaluate their impaired functioning. The SDS does not address and does not include all the disabilities important to subjects with anxiety disorders and susceptible to being affected by drugs with anxiolytic effects, all of which are associated with significant problems. As a single-state-in-time rating, the SDS is often inadequate to discern subtle, but important,changes which may occur between measurements. The SF-36 as a measure of health status can, on the other hand, assess only the patient's behavior most directly affected by the disorder and treatment. As a result, the SF-36 enables the differentiation of functioning and well-being of subjects with anxiety disorders from diverse populations. There is little documentary evidence that demonstrates the value and actual performance of the SDS and SF-36 for the intended purpose. In the absence of a general consensus concerning operational definition, the measurement of disability in this patient population with these scales may be obsolete. There is the need for more specific and simple instruments capable to assess the distinct pattern of impairment associated with subjects with anxiety disorders.

Diagnosis of post-stroke depression (PSD) is extremely difficult due to concomitant focal cognitive disturbances or generalized intellectual impairment, and, in some cases, dissociation of mood and affective behavior. The diagnosis has been standardized on the basis of psychiatric criteria in the Diagnostic and Statistical Manual (DSM)-III, an approach that has been criticized for taking into account non-specific stroke-related somatic symptoms. Yet evaluation of the PSD diagnosis by comparing the severity of depressive symptoms in stroke to an age-matched population sample and by conducting a controlled antidepressant treatment study in unselected PSD patients has failed to disclose any evidence that non-specific symptoms influence the diagnosis of PSD. The prognosis, however, of early vs late diagnosed PSD and the response to treatment of early vs late diagnosed PSD differ, indicating that PSD diagnosed according to DSM-III criteria covers a heterogeneous group of etiologically different conditions.

We have analysed the trial results obtained in two placebo and imipramine controlled double blind studies with a new psychotropic compound. Statistical analysis as outlined in the protocol showed a rather meagre therapeutic effect of imipramine of 1.53 points difference on HAMD-17 total score in comparison to placebo. In order to increase the discriminative power of the analysis we performed a post hoc analysis selecting centres that were able to detect a difference of at least two centres points between imipramine and placebo on HAMD-17 total score at week 6 (selective centres). All other were called nonselective. The analysis revealed that there were no statistically significant differences between the two types of centres concerning patient characteristics except that the nonselective centres recruited less patients with previous good response to antidepressant treatment. There was also some difference in drop out rates in the active treatment group wich might indicate different treatment strategies in the two groups of centres that participated in this trials.

Assessment of quality of life (QoL) and use of this information towards improvement of health care services is an important area of activity of the World Health Organization (WHO). This paper briefly discusses the conceptual basis and the methodology used in WHO's Quality of Life Project (WHOQOL). It describes the simultaneous development of instruments in widely different cultures to assess subjective QoL. Use of these instruments in the field of clinical trials with psychotropics is highlighted.

A literature review identified nearly 500 papers in which references to quality of life (QoL) were made in the context of schizophrenia. Despite this, only two studies could be found where efforts had been made to assess the impact of pharmaceutical products on the QoL of patients with schizophrenia. It is argued that lack of progress in this area of research results from the absence of an adequate schizophrenia-specific QoL instrument. The present paper details the requirements for such an instrument, reviews health status instruments that have been used with schizophrenic patients and describes the methodology required for producing a new instrument. It is argued that the pharmaceutical industry should consider joint financing of such development work, given the importance of a reliable, valid and responsive outcome instrument for clinical trials. Such an instrument would also prove valuable when assessing alternative management programmes.

The assessment of quality of life (QoL) and economic outcomes of psychotropic medications are closely related. Both costs and QoL are important in establishing the value of new and existing drugs in order to assist patients, physicians, payors of health care, and society to make optimal decisions. These parameters may be combined, as in cost-utility analyses, or analysed separately. Although not a true reflection of normal practice, clinical trials are most often the setting for measurement of these parameters. The viability of such analyses, which often necessitate the inclusion of active comparators and additional work measuring costs and QoL, within the context of controlled studies must be established early on in the development process. If ‘registration oriented’ trials are inappropriate, alternative strategies must be pursued.