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1. |
New Technologies to Improve Clinical Trials |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 255-256
Kenneth Kobak,
John Greist,
James Jefferson,
David Katzelnick,
James Mundt,
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ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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2. |
The Association Between Intravenous Haloperidol and Prolonged QT Interval |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 257-261
Kotaro Hatta,
Takeo Takahashi,
Hiroyuki Nakamura,
Hisato Yamashiro,
Nozomu Asukai,
Ichiyo Matsuzaki,
Yosuke Yonezawa,
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摘要:
Although intravenous haloperidol (HAL) is an effective medication that is often prescribed to treat agitation, several instances of torsade de pointes or prolonged QT interval have been reported. To investigate the association between intravenous HAL and QT prolongation and between intravenous HAL and ventricular tachyarrhythmia, a cross-sectional cohort study was performed that included measuring corrected QT intervals (QTc) on an emergency basis before intravenous HAL and continuously monitoring electrocardiographic (ECG) findings after intravenous HAL. During a 2-month period, 47 patients received intravenous injections to control psychotic disruptive behavior. According to clinical practice, patients were divided as follows. The FZ-alone group was treated with intravenous flunitrazepam (FZ), and the FZ-plus-HAL group received intravenous FZ followed by intravenous HAL. Although the difference in the mean QTc immediately after intravenous FZ between the two groups was not significant, the mean QTc after 8 hours in the FZ-plus-HAL group was longer than that in the FZ-alone group (p< 0.001). Four patients in the FZ-plus-HAL group had a QTc of more than 500 msec after 8 hours. The change in QTc during 8 hours significantly differed between the two groups (t= 2.64,p> 0.05). Furthermore, the change in QTc was moderately correlated with the dose of intravenous HAL, as evidenced by a coefficient of correlation of 0.48 (p< 0.001). However, ventricular tachyarrhythmia was not detected among 307 patients within a 1-year period, although the ECG was continuously monitored for at least 8 hours after intravenous HAL. The modest nature of QTc prolongation and the apparent absence of ventricular tachyarrhythmia under continuous ECG monitoring indicate that QTc prolongation associated with intravenous HAL is not necessarily dangerous. However, in an emergency situation, clinicians cannot exclude patients predisposed to torsade de pointes, such as those with inherited ion channel disorders. Therefore, clinicians should be aware of the association between intravenous HAL and QT prolongation.
ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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3. |
The 35% CO2Hyperreactivity and Clinical Symptomatology in Patients With Panic Disorder After 1 Week of Treatment With Citalopram: An Open Study |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 262-267
Angelo Bertani,
Daniela Caldirola,
Riccardo Bussi,
Laura Bellodi,
Giampaolo Perna,
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摘要:
The effect of a short treatment (7 days) with citalopram on the reactivity to inhalations of 35% CO2and 65% oxygen and on clinical symptomatology was investigated in 15 patients with panic disorder who had a positive response to 35% CO2inhalation. An open study design was applied. On day 0, before starting drug treatment, and after 1 week of treatment, each patient underwent the 35% CO2challenge, and clinical symptomatology was evaluated with psychometric scales. The results showed a significant reduction of CO2reactivity and of scores on the anticipatory anxiety subscale of Panic Associated Symptoms Scale. These results confirm that the serotonergic system plays an important role in the modulation of CO2hyperreactivity and suggest an early anxiolytic effect of citalopram in patients who have panic disorder and are hyperreactive to CO2.
ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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4. |
Pharmacokinetics and Clinical Effects of Sublingual Triazolam in Pediatric Dental Patients |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 268-272
Christine Tweedy,
Peter Milgrom,
Evan Kharasch,
Tarja Kaakko,
Martha Spieker,
Susan Coldwell,
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摘要:
The purpose of this investigation was to describe the pharmacokinetics of sublingual triazolam in children. Nine healthy children (64–98 months old) received 0.25 or 0.375 mg of sublingual triazolam before dental treatment. Plasma triazolam concentrations were measured by gas chromatography/ mass spectrometry and analyzed by noncompartmental methods. The peak concentration was 4.9 ± 2.0 ng/mL (mean ± SD), time to peak was 75 ± 32 minutes, the elimination half-life was 91 ± 32 minutes, and apparent clearance was 17.6 ± 8.8 mL · kg−1· min−1. Children were tested for gait ataxia, amnesia, and diplopia during a screening session and again after triazolam. Ninety minutes after drug administration, seven of nine children demonstrated ataxia, and three of nine demonstrated amnesia. Peak triazolam concentrations were similar in children with or without ataxia, but they were significantly higher in children with amnesia compared with those without amnesia. Six children demonstrated diplopia 30 and 120 minutes after triazolam; however, peak triazolam concentrations were similar in both groups. Sublingual administration was an acceptable alternative route of triazolam delivery in children.
ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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5. |
Reinforcing and Subject-Rated Effects of Methylphenidate andd-Amphetamine in Non–Drug-Abusing Humans |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 273-286
Craig Rush,
William Essman,
Cathy Simpson,
Robert Baker,
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摘要:
The reinforcing effects of methylphenidate (20– 40 mg),d-amphetamine (10–20 mg), and placebo were assessed in eight healthy, non–sleep-deprived, non–drug-abusing outpatient volunteers. A modified progressive-ratio schedule was used to assess drug reinforcement in which a sampling session always preceded a self-administration session. During sampling sessions, volunteers received a drug dose to acquaint them with the drug effects. Drug doses were administered in eight identical capsules (i.e., each capsule contained 12.5% of the total dose). During self-administration sessions, which generally were conducted the next day, volunteers were given eight opportunities to work on a computer and could earn all, or some, of the capsules that were administered the previous day. To earn the first capsule, volunteers had to click a computer mouse 50 times. The number of clicks required to earn each additional capsule doubled (i.e., 100, 200, 400, 800, 1,600, 3,200, and 6,400 clicks). The dependent measure on this task was the break point (i.e., the last ratio completed). To characterize more fully the behavioral effects of methylphenidate andd-amphetamine, a battery of subject-rated drug-effect questionnaires, performance tasks, and physiologic measures was also used. Both doses ofd-amphetamine increased the break point significantly above placebo levels, whereas only the high dose of methylphenidate did so. Break-point values for the doses of methylphenidate andd-amphetamine that maintained the greatest responding did not differ significantly. Methylphenidate andd-amphetamine produced some stimulantlike subject-rated drug effects (e.g., increased ratings of “drug liking”). These data suggest that methylphenidate, liked-amphetamine, can function as a reinforcer under a modified progressive-ratio schedule and, by inference, has at least some abuse potential in healthy, non–sleep-deprived, non–drug-abusing volunteers.
ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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6. |
Targeted Use of Naltrexone Without Prior Detoxification in the Treatment of Alcohol Dependence: A Factorial Double-Blind, Placebo-Controlled Trial |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 287-292
Pekka Heinälä,
Hannu Alho,
Kalervo Kiianmaa,
Jouko Lönnqvist,
Kimmo Kuoppasalmi,
John Sinclair,
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摘要:
Several studies have shown the opioid antagonist naltrexone to be effective when combined with psychosocial therapies for the treatment of patients who are dependent on alcohol with fixed medication and time (12 weeks). In this study, 121 nonabstinent outpatients with alcohol dependence (DSM-IV) were treated with sessions of cognitive coping skills (N = 67) or supportive therapy (N = 54) and either naltrexone 50 mg/day (N = 63) or placebo (N = 58) daily for the first 12 weeks and thereafter for 20 weeks only when craving alcohol (i.e., targeted medication) in a prospective one-center, dual, double-blind, randomized clinical trial. The dropout rate for all subjects was 16.5% during the first 12-week period and approximately twice that level by the end of the study. There were no significant group differences in study completion and therapy participation rates. After the continuous medication (12 weeks), the coping/naltrexone group had the best outcome, and coping/placebo had the worst. This difference remained during the targeted medication period (the following 20 weeks). Naltrexone was not better than placebo in the supportive groups, but it had a significant effect in the coping groups: 27% of the coping/naltrexone patients had no relapses to heavy drinking throughout the 32 weeks, compared with only 3% of the coping/placebo patients. The authors’ data confirm the original finding of the efficacy of naltrexone in conjunction with coping skills therapy. In addition, their data show that detoxification is not required and that targeted medication taken only when craving occurs is effective in maintaining the reduction in heavy drinking.
ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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7. |
Antidepressants and Ejaculation: A Double-Blind, Randomized, Placebo-Controlled, Fixed-Dose Study With Paroxetine, Sertraline, and Nefazodone |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 293-297
Marcel Waldinger,
Aeilko Zwinderman,
Berend Olivier,
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摘要:
Antidepressant medication is often associated with sexual side effects. A double-blind, placebo-controlled study in men with lifelong rapid ejaculation was performed to assess the effects of two selective serotonin (5-HT) reuptake inhibitors—paroxetine and sertraline—and the 5-HT2antagonist and 5-HT/noradrenaline reuptake inhibitor nefazodone on the latency to ejaculate. Forty-eight men with an intravaginal ejaculation latency time (IELT) of a maximum of 1 minute were randomly assigned to receive paroxetine (20 mg/day), sertraline (50 mg/day), nefazodone (400 mg/day), or placebo for 6 weeks. During the 1-month baseline and 6-week treatment period, IELTs were measured at home with a stopwatch. The trial was completed by 40 men. During the 6-week treatment period, the geometric mean IELT in the placebo group was stable at approximately 20 seconds. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p= 0.002); the IELT after paroxetine and sertraline gradually increased to approximately 146 and 58 seconds, respectively, compared with 28 seconds in the nefazodone group. The paroxetine and sertraline groups differed significantly (p< 0.001 andp= 0.024, respectively) from placebo, but the nefazodone group did not (p= 0.85). Compared with baseline, paroxetine exerted the strongest delay in ejaculation, whereas sertraline delayed it only moderately. There was no clinically relevant delay in ejaculation with nefazodone.
ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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8. |
The Relative Efficacy of Fluoxetine and Manual-Based Self-Help in the Treatment of Outpatients With Bulimia Nervosa |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 298-304
James Mitchell,
Linda Fletcher,
Karen Hanson,
Melissa Mussell,
Harold Seim,
Ross Crosby,
Mahir Al-Banna,
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摘要:
A randomized, placebo-controlled study was conducted examining the singular and combined effects of fluoxetine and a self-help manual on suppressing bulimic behaviors in women with bulimia nervosa. A total of 91 adult women with bulimia nervosa were randomly assigned to one of four conditions: placebo only, fluoxetine only, placebo and a self-help manual, or fluoxetine and a self-help manual. Subjects were treated for 16 weeks. Primary outcome measures included self-reports of bulimic behaviors. Fluoxetine and a self-help manual were found to be effective in reducing the frequency of vomiting episodes and in improving the response rates for vomiting and binge-eating episodes. Furthermore, both factors were shown to be acting additively on the primary and secondary efficacy measures in this study. Results are discussed in relation to previous research and the implications for treatment of bulimia nervosa.
ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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9. |
MEETING ANNOUNCEMENTS |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 304-304
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ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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10. |
Therapeutic Drug Monitoring of Clozapine in Relapse Prevention: A Five-Year Prospective Study |
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Journal of Clinical Psychopharmacology,
Volume 21,
Issue 3,
2001,
Page 305-310
Ines,
Gaertner Hans,
Gaertner Reinhard,
Vonthein Klaus,
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摘要:
Twenty-three outpatients with schizophrenia (ICD-10 F20.xx) treated with clozapine (CZ) as monotherapy entered a prospective study on relapse prevention. Every 4 weeks, psychopathology was assessed by the Brief Psychiatric Rating Scale (BPRS), and plasma CZ and norclozapine levels were measured. Patients were enrolled after complete remission of positive symptoms for at least 4 months according to the psychosis cluster of the BPRS and at a mean of 3.3 years after their last hospitalization. At the time of enrollment, the median BPRS total score was 29 points (range, 19– 48). Within 4 months, the baseline CZ plasma level was established as the mean of CZ levels from at least four subsequent measurements. These baseline plasma levels were considered as the optimal relapse-preventing plasma CZ levels in the individual patients. When the patients were enrolled, they were considered to be prone to relapse. Relapse was defined as clinical deterioration, hospitalization, or both. Plasma levels were considered a prognostic factor, and patients were defined as at increased risk if plasma levels decreased by more than 40% from baseline CZ plasma level. The effect of plasma CZ levels on clinical outcome was evaluated by a Cox regression with plasma level as a time-dependent covariate. Within 46 months of enrollment, 32 episodes of relapse events in 10 patients were available for evaluation. Seventeen patients had a plasma level decrease of more than 40% at some point. In 12 of these, the decrease was present for more than 12% of the observation period. Eight patients of this group relapsed, and three of these had to be rehospitalized. Two patients relapsed, although their plasma levels decreased by more than 40% for less than 12% of the observation period. Within the first 2 years, relapse-free survival curves illustrate that both groups (episodes under elevated risk and episodes not under elevated risk) had identical relapse patterns, but from then on the relapse risk increased rapidly in the group with longer exposure to elevated risk. In a Cox model with a 40% decrease of plasma CZ levels as a dichotomous time-varying explanatory covariate, the risk ratio is 6 (95% confidence interval = 2–19,p= 0.003). The 10 patients who relapsed exhibited safe plasma levels (less than a 40% decrease from their baseline levels) for only 210 months, and 13 nonrelapsing patients had plasma levels defined as safe for 426 months.
ISSN:0271-0749
出版商:OVID
年代:2001
数据来源: OVID
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