ABSTRACT
The safety and efficacy of sertraline versus placebo were examined in a group of nondepressed outpatients with obsessive-compulsive disorder (OCD). Patients with moderate-to-severe OCD were recruited at 10 sites. After a 1-week placebo lead-in, patients were treated in a double-blind fashion for 12 weeks with sertraline or placebo. Sertraline was administered at a starting dose of 50 mg/day, with flexible titration up to 200 mg/day. The efficacy measures were the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the National Institute of Mental Health Global Obsessive Compulsive Scale (NIMH), and the Clinical Global Impression Scale (CGI) Severity of Illness and Improvement subscales. One hundred sixty-seven patients were randomly assigned and received at least one dose of double-blind medication: 86 received sertraline and 81 received placebo. All efficacy measures showed significantly greater improvement in the sertraline group from the end of week 8 until the end of week 12. Significantly greater improvement (p < 0.05) in the sertraline group first became apparent by the end of week 3 on the Y-BOCS and the CGI Improvement scale, and by the end of weeks 6 and 8, respectively, on the NIMH and CGI Severity scale. Sertraline was well tolerated, without serious adverse effects. In conclusion, sertraline was safe and effective in the treatment of patients with OCD.
Subject(s)
Obsessive-Compulsive Disorder/drug therapy , Sertraline/therapeutic use , Adult , Female , Humans , Male , Middle Aged , Obsessive-Compulsive Disorder/psychology , Psychiatric Status Rating ScalesABSTRACT
OBJECTIVE: The purpose of this study was to determine if plasma clozapine levels were associated with treatment response. METHOD: To examine this question, neuroleptic nonresponsive patients with schizophrenia or schizoaffective disorder were given clozapine, which was titrated to 500 mg/day by day 14 of treatment, and the dose was held fixed at least through day 21. Subsequently, clozapine doses were adjusted as clinically indicated, up to a maximum of 900 mg/day. Plasma clozapine levels were obtained at weeks 3 and 6, and standard clinical ratings (Brief Psychiatric Rating Scale [BPRS] and Clinical Global Impression) were done at baseline and at weeks 3 and 6. RESULTS: Data from 45 subjects were analyzed. There were no correlations between plasma clozapine levels and change in BPRS scores at treatment weeks 3 and 6. However, when the subjects were classified as responders or nonresponders, therapeutic response was associated with clozapine blood levels above 350 ng/ml. CONCLUSIONS: This study suggest that clozapine blood levels are correlated with clinical response.
Subject(s)
Clozapine/blood , Schizophrenia/drug therapy , Adult , Antipsychotic Agents/therapeutic use , Clozapine/therapeutic use , Drug Resistance , False Positive Reactions , Female , Humans , Male , Psychiatric Status Rating Scales , Psychotic Disorders/blood , Psychotic Disorders/drug therapy , ROC Curve , Schizophrenia/blood , Schizophrenia/diagnosis , Sensitivity and Specificity , Treatment OutcomeABSTRACT
Clinical and biological measures were examined for their relationship to clinical response to clozapine. Associations were found between therapeutic response and the following variables: male gender, paranoid schizophrenia subtype diagnosis, older age at onset of illness, shorter duration of illness, higher levels of pretreatment acute EPS, low pretreatment CSF HVA/5-HIAA, greater decrease in prolactin (PRL) and increase in growth hormone (GH) response to apomorphine stimulation pretreatment and greater inhibition by clozapine treatment of PRL and GH response to apomorphine, and plasma clozapine levels above 350 ng/mL. These results are consistent with other investigators' findings and have practical and heuristic implications for the use of clozapine and understanding its mechanism of action.
Subject(s)
Clozapine/therapeutic use , Schizophrenia/drug therapy , Adult , Age Factors , Age of Onset , Antipsychotic Agents/adverse effects , Apomorphine/pharmacology , Basal Ganglia Diseases/chemically induced , Basal Ganglia Diseases/epidemiology , Clozapine/blood , Clozapine/pharmacology , Female , Growth Hormone/blood , Humans , Male , Probability , Prolactin/blood , Schizophrenia/blood , Schizophrenic Psychology , Sex Factors , Treatment OutcomeABSTRACT
Despite long-standing concerns over hypertensive reactions, monoamine oxidase inhibitors (MAOIs) have grown in popularity and are now used in a variety of psychiatric disorders. The risk of hypertensive episodes is less than 1%. This is most likely the result of careful dietary instructions and prudent prescribing of concomitant medications. The possibility exists of spontaneous or unprovoked hypertensive crises in patients receiving MAOIs. In this report, we review the literature on spontaneous hypertensive episodes and present a case report. There has been a total of 11 cases described in six separate reports. We discuss the possible mechanism, risk factors, treatment, and safety of rechallenging the patients with the MAOI. Further research is needed to clarify this reaction. For now, it remains a rare but worrisome phenomenon. It should stand as an additional source of concern for clinicians who are already well aware of the risk of hypertensive episodes in patients receiving MAOIs.
