Sulpiride and Haloperidol in Schizophrenia: A Double-blind Cross-over Study of Therapeutic Effect, Side Effects and Plasma Concentrations

1985 ◽  
Vol 147 (3) ◽  
pp. 283-288 ◽  
Author(s):  
Jes Gerlach ◽  
Kirsten Behnke ◽  
Jon Heltberg ◽  
Ebbe Munk-Andersen ◽  
Henrik Nielsen
Keyword(s):  
Side Effects ◽  
Plasma Concentrations ◽  
Clinical Effects ◽  
Median Dose ◽  
Double Blind ◽  
Day Range ◽  
Daily Dose ◽  
Schizophrenic Patients ◽  
High Doses ◽  
Therapeutic Profile

SummaryIn a double-blind cross-over trial, 20 chronic schizophrenic patients were treated with sulpiride and haloperidol in two 12-week periods. The final median dose of sulpiride was 2000 mg/day (range 800–3200) and of haloperidol 12 mg/day (range 6–24). Sulpiride had an antipsychotic effect and therapeutic profile not significantly different from that of haloperidol. In spite of the high doses of sulpiride, extrapyramidal side-effects were seen less frequently during the first four weeks of the sulpiride period than during the corresponding haloperidol period (P < 0.05), whereas autonomic side-effects were equally rare for both drugs. A positive correlation was found between daily dose and plasma concentration of both sulpiride (P < 0.001) and haloperidol (P < 0.05), but no correlation could be established between clinical effects and plasma levels of either neuroleptic.

A Comparative Trial of Opipramol and Chlordiazepoxide in the Treatment of Anxiety

1973 ◽  
Vol 1 (3) ◽  
pp. 145-150 ◽  
Author(s):  
K Jepson ◽  
G Beaumont
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Rating Scale ◽  
Comparative Trial ◽  
Anxiety Score ◽  
Double Blind ◽  
Somatic Anxiety ◽  
Daily Dose ◽  
The Difference

A daily dose of 200 mg of opipramol (Insidon, Geigy) and 30 mg of chlordiazepoxide (Librium, Roche) were compared in a clinical trial in general practice. The trial was double blind and a stratified randomisation technique was employed. Twenty four patients received opipramol and twenty six chlordiazepoxide for four weeks. A total anxiety score and separate ‘psychic’ anxiety and ‘somatic’ anxiety scores were recorded, using a rating scale initially and after two and four weeks treatment. No overall difference in efficacy was found between the two drugs—opipramol producing a 76% improvement and chlordiazepoxide 64% by the end of the study. There was no difference in the relief of psychic anxiety. Although opipramol appeared to give more relief of somatic anxiety, the difference was not statistically significant. Again although opipramol relieved more individual symptoms than chlordiazepoxide, none of the differences were significant. 70% of patients on opipramol and 74% of those on chlordiazepoxide were classified ‘better’ globally by both doctor and patient by the end of the trial. The total number of side effects recorded was similar on both drugs although drowsiness occurred twice as frequently on chlordiazepoxide as it did on opipramol.

A Comparison of the Clinical Effects of Timiperone, a New Butyrophenone Derivative, and Haloperidol on Schizophrenia Using a Double-Blind Technique

1983 ◽  
Vol 11 (2) ◽  
pp. 66-77 ◽  
Author(s):  
T Kariya ◽  
Y Shimazono ◽  
H Itoh ◽  
A Mori ◽  
M Murasaki ◽  
...  
Keyword(s):  
Controlled Study ◽  
Clinical Effects ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Global Improvement ◽  
Daily Dose ◽  
Drug Treatments ◽  
Improvement Rating

The efficacy and safety of timiperone, a new butyrophenone derivative, in schizophrenia as compared with haloperidol were assessed in a multi-clinic double-blind controlled study in a total of 206 patients. The patients were given timiperone (1·0 mg/tablet) or haloperidol (1·5 mg/tablet) in a daily dose of 1–3 tablets for the first day, then up to a maximum of 12 tablets depending on symptoms for 12 weeks. Timiperone was found to be significantly superior to haloperidol in the final global improvement rating and in the general usefulness rating. In the over-all safety rating there were no statistically significant differences between the two drug treatments. With regard to analysis by stratification timiperone was superior to haloperidol in improving abnormal experiences such as hallucination and delusion as well as deficiency of initiative and blunted affect. From these results it is considered that timiperone could be superior to haloperidol in the treatment of schizophrenia.

Neuroleptic Prescription for Chinese Schizophrenics in Hong Kong

1992 ◽  
Vol 26 (2) ◽  
pp. 262-264 ◽  
Author(s):  
Helen Chiu ◽  
Sing Lee ◽  
C.M. Leung ◽  
Y.K. Wing
Keyword(s):  
Hong Kong ◽  
Side Effects ◽  
High Frequency ◽  
Anticholinergic Drugs ◽  
Extrapyramidal Side Effects ◽  
High Potency ◽  
Frequency Of Use ◽  
Daily Dose ◽  
Schizophrenic Patients ◽  
The Mean

There are very few studies on the pattern of neuroleptic prescription for schizophrenics in Asia. 106 schizophrenic patients in a psychiatric unit of a general teaching hospital in Hong Kong were surveyed. The mean daily dose (in chlorpromazine equivalent) was low (568.5mg). The mean daily dose of high potency agents was four times that of low potency agents. A high frequency of use of anticholinergic drugs may indicate that Chinese are more susceptible to acute extrapyramidal side-effects.

A Comparison of Two Butyrophenones with Trifluoperazine

1966 ◽  
Vol 11 (1) ◽  
pp. 26-30 ◽  
Author(s):  
G. Marjerrison ◽  
W. Hrychuk ◽  
E.I. Varsanyi
Keyword(s):  
Side Effects ◽  
Rating Scale ◽  
Drug Action ◽  
Small Study ◽  
Clinical Effects ◽  
Double Blind ◽  
Morbidity Score ◽  
Closed Ward

A small study was carried out to compare the clinical effects of the two butyrophenone compounds, triperidol and haloanisone to those of trifluoperazine, in a population of chronically hospitalized long-term schizophrenics in a closed ward setting. Twenty-seven patients were randomly assigned to one of the three compounds, and treated for a twelve-week period under double-blind conditions. Observations with a modified PRP rating scale, based on ward nurses' monthly ratings, revealed an over-all improvement after one month of treatment, but differences between the three drugs were not apparent and the over-all decrease of this PRP morbidity score was not sustained in subsequent ratings. Psychiatrist's ratings on the IMPS revealed several symptom-factor differences with treatment. Between-drug differences on these factors were apparent. They are discussed in terms of the possible differences in type of drug action which they may reflect. The incidence of parkinsonistic side effects with each drug is presented. In no case did the side effects prevent continued treatment with the compound.

scholarly journals Double-Blind Cross-Over Placebo Controlled Study of Flunarizine in Patients With Therapy Resistant Epilepsy

1989 ◽  
Vol 16 (2) ◽  
pp. 187-190 ◽  
Author(s):  
E. Starreveld ◽  
F. de Beukelaar ◽  
A.F. Wilson ◽  
D.R. McLean ◽  
Helen P. Findlay
Keyword(s):  
Placebo Group ◽  
Depressive Symptoms ◽  
Side Effects ◽  
Seizure Frequency ◽  
Controlled Study ◽  
Double Blind ◽  
Adverse Side Effects ◽  
Generalized Seizures ◽  
Daily Dose ◽  
The Mean

ABSTRACT:Twenty-five patients with long-standing therapy resistant epilepsy were studied in an eight-month double- blind cross-over add-on trial with a daily dose of 15 mg flunarizine. In five patients the seizure frequency decreased 50% or more. The mean seizure frequency reduction in the patients on flunarizine was 35%. Particularly the control of secondary generalized seizures improved. Flunarizine did not significantly alter the plasma levels of the regular anticonvulsant drugs. Minimal adverse side effects were reported equally in the flunarizine and the placebo group. In three patients depressive symptoms improved and two patients became free of postictal headaches. Flunarizine appears to be a safe adjuvant anticonvulsant.

Dose and duration of dexamethasone in patients with high grade gliomas (HGG): Relationship to steroid myopathy (SM)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18517-18517
Author(s):  
J. O. Blakeley ◽  
T. Peng ◽  
X. Ye ◽  
S. A. Grossman
Keyword(s):  
Johns Hopkins Hospital ◽  
High Dose ◽  
Average Daily Dose ◽  
Respiratory Compromise ◽  
Treatment Interventions ◽  
Steroid Myopathy ◽  
Day Range ◽  
Peak Dose ◽  
Daily Dose ◽  
High Doses

18517 Background: Steroids are critical in the management of HGG due to their ability to control peri-tumoral edema. Myopathy is a disabling complication of steroids leading to loss of ambulation and respiratory compromise. We sought to describe the use of steroids in the first 8 months after the diagnosis of HGG and its relationship to SM. Methods: Charts of all adults with HGG diagnosed and treated at Johns Hopkins Hospital from June 2004 to May 2005 were reviewed. Patients who died in less than 8 months were excluded. Starting steroid dose, subsequent documented doses, initial date and dates of change were recorded. Only charts with the phrase “steroid myopathy” were defined as SM positive. Results: Twenty-eight patients met all inclusion criteria. The mean age was 57.2 ± 8.7 years and 19 (67.8%) were males. All patients (100%) received steroids. Dexamethasone was used exclusively. Ninety-three percent of patients received >16mg/day and 36% were on >16mg/day for at least a month. The average daily dose was 15.3 ± 7.1 mg. Mean cumulative dose was 2.8 ± 1.8 grams. The median peak dose was 40mg/day (range 16–120mg/day). Median days on steroids was 224 days (range 5–224 days) from diagnosis and 67.8% of patients were on continuous steroids for 8 months. Eleven (39% [95% CI: 22%-59%]) of the 28 patients were defined as SM. Seven of the 11 (63.6%) SM patients required wheelchairs versus two (11.8%) without SM (p = 0.004). Days on steroid was significantly longer (p = 0.012) in the SM group (214 ± 32 days) versus the non-SM group (155 ± 81days). No strong evidence supported differences between groups in total dose, average daily dose, peak dose or days on high dose steroids. Conclusions: Patients with HGG are exposed to high doses of steroids for long periods. SM was noted in 39% of our patients and most required wheelchairs within 8 months of diagnosis. These figures are likely significant underestimates given the amount of steroids administered and the retrospective nature of this study. Our data confirm prior reports of an association between duration of steroid use and SM. The findings highlight the need to prevent SM using alternate dosing schedules and agents and to develop effective treatment interventions for SM. No significant financial relationships to disclose.

Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone

2019 ◽  
Vol 15 (5) ◽  
pp. 417-427
Author(s):  
Joseph S. Gimbel, MD ◽  
Richard L. Rauck, MD ◽  
Almasa Bass, PharmD ◽  
Jacquelyn Wilson, PharmD ◽  
Glenn Pixton, MS ◽  
...  
Keyword(s):  
Plasma Concentrations ◽  
Fixed Dose ◽  
Opiate Withdrawal ◽  
Efficacy Study ◽  
Clinical Effects ◽  
Open Label ◽  
Safety Study ◽  
Two Phase ◽  
Double Blind ◽  
Chronic Noncancer Pain

Objective: To evaluate the clinical effects of naltrexone following ALO-02 administration.Design: Two phase three studies: an open-label, single-arm safety study, and a double-blind, placebo-controlled, randomized withdrawal, efficacy study (ClinicalTrials.gov identifiers: NCT01428583, NCT01571362).Setting: Seventy US research centers.Patients: Eight hundred and five patients with moderate-to-severe chronic noncancer pain (n = 395) or moderate-to-severe chronic low back pain (n = 410).Interventions: Oral ALO-02 capsules (daily dose 20-160 mg oxycodone): openlabel titration followed by double-blind fixed dose ALO-02 or placebo (12 weeks) for the efficacy study; and open-label administration (≤12 months) for the safety study.Main outcome measures: Brief Pain Inventory-Short Form (BPI-sf), withdrawal-related adverse events, Clinical Opiate Withdrawal Scale (COWS), and naltrexone plasma concentrations.Results: ALO-02 was received for 30 days by 592 patients (73.5 percent), 90 days by 348 patients (43.2 percent), and ≥361 days by 105 patients (13.0 percent). Maximum COWS scores were below the cutoff for mild withdrawal for the majority of patients: 86.6 percent of patients in the safety study, and for the efficacy study, 96.8 percent during titration and 95.0 percent during double-blind treatment. The frequency of quantifiable naltrexone plasma concentrations was similar between studies (18-23 percent of samples), and the levels were low, generally not exceeding 200 pg/mL. There was no apparent relationship between naltrexone plasma concentrations and COWS scores (total or change from baseline), or change from baseline in BPI-sf scores in the efficacy (R 2 = 0.0184, 0.0224, and 0.0173, respectively) or safety studies (R 2 = 0.0010, 0.0000, and 0.0122, respectively).Conclusions: Naltrexone plasma concentrations were low, not correlated with COWS or BPI-sf scores, and considered clinically insignificant.

Propranolol in Chronic Schizophrenia: A Controlled Study in Neuroleptic-Treated Patients

1980 ◽  
Vol 137 (2) ◽  
pp. 126-130 ◽  
Author(s):  
Leif H. Lindström ◽  
Eva Persson
Keyword(s):  
Rating Scale ◽  
Chronic Schizophrenia ◽  
Placebo Treatment ◽  
Controlled Study ◽  
Psychotic Symptoms ◽  
Double Blind ◽  
Schizophrenic Patients ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale ◽  
High Doses

The effect of propranolol at a dose level of 1,280–1,920 mg per day was studied with a double-blind crossover design in twelve chronic schizophrenics with persistent psychotic symptoms despite maintenance treatment with a depot neuroleptic. By use of a psychiatric rating scale (CPRS), an improvement was seen during the two week period of propranolol compared to placebo treatment in six patients, whereas three patients were unchanged and three deteriorated. The effect on total symptom scores for the whole group was significantly better after propranolol. The data indicate that propranolol in high doses has an antipsychotic effect in some schizophrenic patients when receiving neuroleptics.

A Double-Blind Comparative Trial of Loxapine and Trifluoperazine in Acute and Chronic Schizophrenic Patients

1976 ◽  
Vol 4 (6) ◽  
pp. 441-448 ◽  
Author(s):  
L G Kiloh ◽  
S E Williams ◽  
D A Grant ◽  
P S Whetton
Keyword(s):  
Side Effects ◽  
Laboratory Tests ◽  
Urine Analysis ◽  
Comparative Trial ◽  
Chronic Patients ◽  
Double Blind ◽  
Anticholinergic Effects ◽  
Chronic Schizophrenic ◽  
Schizophrenic Patients

A double-blind comparative trial of loxapine and trifluoperazine was carried out in 57 acute and chronic schizophrenic patients. In both groups of patients loxapine proved to be equivalent in its effects to trifluoperazine and there were suggestions it might be rather more effective in chronic patients. Side-effects were simitar with the two drugs but anticholinergic effects, excitement, dizziness and faintness occurred rather more commonly with loxapine. Laboratory tests, urine analysis, cardiovascular and ophthalmological investigations showed no significant abnormalities.

Paliperidone Palmitate and Quality of Life in Schizophrenia

2017 ◽  
Vol 41 (S1) ◽  
pp. S268-S268
Author(s):  
N.B. Juan Carlos ◽  
B. Girela ◽  
A. Maria Angeles
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Clinical Symptoms ◽  
Oral Treatment ◽  
Paranoid Schizophrenia ◽  
World Health ◽  
Paliperidone Palmitate ◽  
Double Blind ◽  
Schizophrenic Patients

There is growing interest in the study of the quality of life of mental disorders in general, and particularly in schizophrenia. The quality of life is defined by the world health organization as the perception that an individual has of his place in existence, in the context of culture and value system in which they live and in relation to its objectives, their expectations, their rules, their concerns. Paliperidone palmitate is a depot anti-psychotic treatment monthly application is indicated for maintenance treatment of schizophrenia in adult patients. In this work the quality of life in 5 subjects with a diagnosis of paranoid schizophrenia (less than 10 years of diagnosis) is evaluated, all males, aged between 42 and 45 years and with poor adherence to oral treatment. The patients received an average of paliperidone palmitate 100 mg/month. We evaluate the quality of life at baseline and after 3 months – BREF quality of life (WHOQOL – BREF) Scale Quality of Life (QOLS) and WHO was used. The results showed significant improvements in major QOLS scale in all subjects. There were no significant differences in total score WHOQL – BREF scale, but if there was improvement in the scores of some subscales. They no side effects evaluated in the UKU scale. The quality of life in schizophrenic patients can be affected by the presence of, particularly cognitive and negative clinical symptoms. New treatments as paliperidone palmitate improve adherence and have fewer side effects can improve the perceived quality of life. However, they need more extensive studies double-blind evaluation.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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