ABSTRACT
BMY 21,502 is a nootropic which protects memory and enhances long-term potentiation according to preclinical findings. Alzheimer's disease (AD) patients who were diagnosed by DSM-III-R and NINCDS-ADRDA criteria were enrolled in a 12-week double-blind investigation of BMY 21,502 vs. placebo at 300 mg tid. The study design included a 1-week placebo lead-in and a 4-week placebo washout in addition to the 12-week double-blind treatment period. Efficacy was assessed with the Alzheimer's Disease Assessment Scale (ADAS) and the Computerized Neuropsychological Test Battery (CNTB) at weeks 4, 8, 12, and 16. Clinical Global Impression (CGI) assessments were also performed biweekly. Sixty-nine patients (28M, 41F; mean age 72 years, range 54 to 92 years) were enrolled in the study. Baseline Mini-Mental Status Examination (MMSE) scores ranged from 16 to 26 (mean 23.5) in patients on active drug (n = 34), and from 15 to 26 (mean 22.5) in placebo patients (n = 35). Baseline efficacy scores were comparable for drug and placebo patients (p > 0.05). Twelve (35%) patients who received BMY 21,502 withdrew from the study, 8 (24%) due to adverse events. Three (9%) patients who received placebo withdrew from the study, all due to adverse events. Patients on active drug who were valid for analysis of efficacy (n = 22) showed a mean decrease in ADAS of -1.5 at week 12, vs. a mean change of -0.5 in patients who received placebo (n = 32), although there was no significant difference between the two (p > 0.05). Correlations between the CNTB summary scores and ADAS cognitive subscores were, nevertheless, highly significant at baseline (r = -0.83, p = 0.0001) and week 12 (r = -0.83, p = 0.0001). Correlations between the word list learning, spatial, and naming subtests of the ADAS and CNTB were also highly significant (p = 0.0001). Although modest, the findings for active drug vs. placebo response in this study suggest that BMY 21,502 should be further investigated, with a larger study population, in order to fully determine the compound's potential efficacy.
Subject(s)
Alzheimer Disease/drug therapy , Neuropsychological Tests , Psychotropic Drugs/therapeutic use , Pyrimidines/therapeutic use , Pyrrolidinones/therapeutic use , Aged , Aged, 80 and over , Alzheimer Disease/psychology , Double-Blind Method , Female , Humans , Male , Middle Aged , Placebos , Pyrimidines/toxicity , Pyrrolidinones/toxicityABSTRACT
Gepirone is a serotonin (5-hydroxytryptamine, 5-HT) type1A receptor agonist and a pharmacologic analogue of buspirone. Two double-blind, placebo-controlled studies show the efficacy of gepirone in the treatment of major depression. Study 1 demonstrates gepirone's superiority over placebo in an 8-week acute treatment of patients with major depression, including the melancholic subtype. Gepirone's antidepressant dose range is tentatively established at 5-30 mg/day. Study 2 reveals the benefit of gepirone compared with placebo in 4-week continuation therapy of patients with major depression who initially responded to 6 weeks of open therapy with gepirone. Analysis of Hamilton Rating Scale for Depression item scores show gepirone especially improves scores on items of core depression.
Subject(s)
Anti-Anxiety Agents , Depressive Disorder/drug therapy , Pyrimidines/administration & dosage , Adult , Aged , Depressive Disorder/psychology , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Psychiatric Status Rating Scales , Randomized Controlled Trials as TopicSubject(s)
Behavior Therapy , Obesity/therapy , Adult , Child , Diet Fads , Female , Humans , Male , Obesity/etiology , Obesity/psychologyABSTRACT
A prospective study was undertaken to evaluate the use of the flexible plastic cannula for obtaining endometrial specimens for diagnostic purposes. Suction curettage was performed immediately prehysterectomy, the specimens evaluated, and then compared to similar specimens obtained by a metal curette. Another group of patients had suction curettage performed as an office procedure 24 to 72 hours before hysterectomy. The results of our study confirm the adequacy of this method for obtaining endometrial samples.
Subject(s)
Catheterization , Curettage/methods , Endometrium/pathology , Adult , Aged , Female , Humans , Middle Aged , Uterine Neoplasms/diagnosisABSTRACT
PIP: 20 patients underwent intraamniotic administration of PGF2alpha for termination of pregnancies ranging from 14-20 weeks gestation. Success was achieved in 18 patients (90%) with this method. The 2 failures were terminated vaginally with adjunctive use of intracervical laminaria and intravenous pitocin induction. 10 of the patients had intracervical laminaria placed 4-24 hours prior to drug administration. This latter group was noted to have a shorter induction-abortion interval, shorter onset of uterine contractions, and a decreased incidence of vaginal bleeding prior to abortion. No serious side effects occurred in either group of patients. Clinical toxicity in the form of gastrointestinal symptoms such as nausea and vomiting were common but could generally be controlled with antiemetics. No significant changes were recorded in blood counts, platelet counts, liver function tests, and renal function tests from pretreatment values and at 24 and 48 hours posttreatment. There were no instances of hemorrhage, fever, or infection which occur as complications of hypertonic saline abortion.^ieng
