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The efficacy and tolerability of the new antidepressant Org 3770 were evaluated in a multicentre, double-blind, clomipramine-controlled trial. In total, 174 patients (126 women and 48 men), aged 18-75 years. who were suffering from a moderate or severe major depressive episode, were randomly assigned to 6 weeks of treatment with either Org 3770, 20-80 mg/day, or clomipramine, 50- 200 mg/day. All patients were hospitalized at the time of the trial. Depressive symptoms, assessed by 21-item HPRSD, MAURS, BPRS and GAS, improved significantly in both groups of patients after 6 weeks of treatment. Org 3770 was comparable to clomipramine with respect to improvements assessed by all the primary efficacy variables, both in moderately and severely depressed patients. Adverse clinical experiences, such as dry mouth, constipation, tremor, vertigo/dizziness, faintness on rising, and nausea, were reported by fewer patients in the Org 3770-treated group than in the clomipramine-treated group. These differences were particularly pronounced during the first 3 weeks of treatment, With respect to tremor, the difference between the two groups was statistically significant (p2sided = 0.03) after both 3 and 6 weeks of treatment. This study shows that Org 3770 is as effective as clomipramine in treating moderate or severe depression. white being better tolerated. [ABSTRACT FROM AUTHOR]

In light of the number of studies conducted to examine the treatment of cognitive impairment associated with schizophrenia (CIAS), we critically reviewed recent CIAS trials. Trials were identified through searches of the website "www.clinicaltrials.gov" using the terms "schizophrenia AND cognition," "schizophrenia AND neurocognition," "schizophrenia AND neurocognitive tests," "schizophrenia AND MATRICS," "schizophrenia AND MCCB," "schizophrenia AND BACS," "schizophrenia AND COGSTATE," and "schizophrenia AND CANTAB" and "first-episode schizophrenia AND cognition." The cutoff date was 20 April 2011. Included trials were conducted in people with schizophrenia, the effects on cognition were either a primary or secondary outcome, and the effect of a pharmacologically active substance was examined. Drug challenge, pharmacokinetic, pharmacodynamic, or prodrome of psychosis studies were excluded. We identified 118 trials, with 62% using an add-on parallel group design. The large majority of completed trials were underpowered to detect moderate effect sizes, had ≤8 weeks duration, and were performed in samples of participants with chronic stable schizophrenia. The ongoing add-on trials are longer, have larger sample sizes (with a number of them being adequately powered to detect moderate effect sizes), and are more likely to use a widely accepted standardized cognitive battery (eg, the MATRICS Consensus Cognitive Battery) and MATRICS guidelines. Ongoing studies performed in subjects with recent onset schizophrenia may help elucidate which subjects are most likely to show an effect in cognition. New insights into the demands of CIAS trial design and methodology may help increase the probability of identifying treatments with beneficial effect on cognitive impairment in schizophrenia.