PubMed Health⌕ Search

Biomedical subjects

P Sarteschi

Publications and source records attributed to P Sarteschi.

12 recordsLinked to original sources
PubMed1993

A double-blind, placebo-controlled study of fluoxetine in patients with DSM-III-R obsessive-compulsive disorder. The Lilly European OCD Study Group.

We have studied the effect of three fixed daily doses of fluoxetine in patients with obsessive-compulsive disorder (OCD) diagnosed according to DSM-III-R. Two hundred and fourteen patients were evaluated in an 8-week double blind, placebo-controlled study. A statistically significantly greater number of fluoxetine-treated patients achieved the prospectively defined criteria for clinical response when compared to placebo treatment. There was a statistically significant overall difference in the PGI rating of symptom change (P = 0.045) and a marginally significant difference (P = 0.089) in the CGI severity rating between groups. Pairwise comparison against placebo showed a marginally statistically significantly greater improvement (P = 0.059) in Y-BOCS-Total score for patients receiving fluoxetine 60 mg daily, and a significantly higher response rate in patients receiving fluoxetine 40 mg or 60 mg daily (P < 0.05). One hundred and sixty one patients continued to a 16-week extension evaluation. There was no significant difference in the rate of reporting of any individual adverse event between placebo and fluoxetine, and the rate of discontinuation due to adverse events was low (< 6% in each study phase). This study supports the growing evidence for the safety and efficacy of fluoxetine in the treatment of OCD.

Adolescent↗
PubMed1993

[Treatment of insomnia related to depressive disorders. Effects of zolpidem versus flunitrazepam administration and withdrawal evaluated in a double-blind study].

The effects of a 15 day treatment with zolpidem (10 mg) and with flunitrazepam (1 mg) on Insomnia Disorders Related to Depressive Disorders (DSM-III-R) have been evaluated on 30 depressive in-patients (mean age 42.3 +/- 9.8). The trial has been carried out on double blind condition after 5 days of single blind placebo administration. Withdrawal effects have been evaluated in single blind condition on a 10 day period after drugs discontinuation. Patient's diagnosis was Major Depression or Dysthymia according to DSM-III-R; inclusion criteria were insomnia (total sleep time < or = 6 h, sleep latency > or = 30 min, wake after sleep onset > or = 30 min, No of awakenings > or = 3) refractory to clomipramine administration at constant dose (75-150 mg/day among patients). Both drugs have been followed by a rapid, significant diminution of insomnia as demonstrated by significant changes at Stanford Sleepiness Scale and Saint Mary Hospital Sleep Questionnaire and by a significant reduction of HDRS total scores. No clinical phenomena of rebound insomnia were detected after zolpidem and flunitrazepam withdrawal. Drug discontinuation however was followed by the slow increase of the score on insomnia items, approximating basal values at the end of the 10 day period after zolpidem and flunitrazepam withdrawal. A parallel increase of HDRS total score was also detected; HDRS changes were mainly due to the increase of the items anxiety somatic, general somatic symptoms, gastrointestinal somatic symptoms, hypochondriasis. The study confirms the therapeutic efficacy of zolpidem and of flunitrazepam in the treatment of insomnia resistant to antidepressant drugs in depressed patients. They also suggest that early drug discontinuation is frequently associated with clinical relapse of insomnia and of several other symptoms correlated with the affective pathology.

Adult↗
PubMed1979

Clinical trials in psychopharmacology: scientific and ethical issues.

1. The ethical and scientific use of medicines for the treatment of illness rests upon proof that the medicines to be used are effective and safe for the condition to be treated. The use of the clinical trial is the method by which such evidence is produced. 2. Recent activities by some to decry clinical trials as unethical and restrict their conduct results in the totally unacceptable situation of withholding potentially valuable treatments from patients or subjecting patients to the unnecessary risks of treatments not proven safe and efficacious. These actions can lead to a new dark age of "chemotherapeutic blood letting and purgatives" under the guise of higher ethical purposes.

Clinical Trials as Topic↗
PubMed1976

An automated diagnostic process (PDA) in clinical psychopharmacology. An exemplification of its use in a sulpiride versus haloperidol comparative trial.

One of the main unsolved problems, and one which produces divergent results in clinical psychopharmacology, is that concerning the selection of patients and their diagnostic definition. An automated diagnostic procedure (PDA) was set up in order to classify each patient into one nosographic category on the basis of a cross-sectional examination of his mental state. Such diagnostic procedure appears particularly suitable for multicenter drug trials, since it gives a profile and a diagnostic definition of patients, assessed by investigators from different areas and with different cultural, and clinical backgrounds. In a multicenter trial (sulpiride versus haloperidol) PDA offered a chance to re-examine and analyze the characteristics of each patient and therefore to control the criteria followed for the sample selection in the various experimental settings. The agreement between clinician and computer diagnosis was 78.9%; this agreement rises to 85.5% if the computerlabelled schizo-affective syndromes are considered within the schizophrenic group. Moreover, and attempt has been made to relate psychopathological patterns to drug responses.

Adult↗