The Antiaggressive Action of Combined Haloperidol-Propranolol Treatment in Schizophrenia

2000 ◽  
Vol 5 (4) ◽  
pp. 312-325 ◽  
Author(s):  
Gadi Maoz ◽  
Daniel Stein ◽  
Sorin Meged ◽  
Larisa Kurzman ◽  
Joseph Levine ◽  
...  
Keyword(s):  
Rating Scales ◽  
Double Blind ◽  
Propranolol Group ◽  
Schizophrenic Patients ◽  
Propranolol Treatment ◽  
Simultaneous Decrease ◽  
The Mean ◽  
Haloperidol Treatment ◽  
To Receive ◽  
Drug Free

Psychopharmacological interventions for managing aggression in schizophrenia have thus far yielded inconsistent results. This study evaluates the antiaggressive efficacy of combined haloperidol-propranolol treatment. Thirty-four newly admitted schizophrenic patients were studied in a controlled double-blind trial. Following a 3-day drug-free period and 7 days of haloperidol treatment, patients were randomly assigned to receive either haloperidol-propranolol or haloperidol-placebo for eight consecutive weeks. Doses of medications were adjusted as necessary; biperiden was administered if required. Rating scales were applied to assess aggression, anger, psychosis, depression, anxiety and extrapyramidal symptoms. The mean daily dose of haloperidol was 21 mg (SD = 6.4) in the research group and 29 mg (SD = 6.9) in the controls. Mean and maximal daily doses of propranolol were 159 mg (SD = 61) and 192 mg (SD = 83), and of placebo, 145 mg (SD = 50) and 180 mg (SD = 70), respectively. Compared with the controls, the scores for the research patients decreased significantly from baseline, particularly after 4 weeks of treatment, for some dimensions of anger, psychosis, anxiety, and neuroleptic-induced parkinsonism. A tendency for reduced aggression was shown in the combined haloperidol-propranolol group for some dimensions but not others. These patients also required significantly less biperiden. The tendency toward elevated antiaggressive effect of combined haloperidol-propranolol treatment compared to haloperidol alone may be explained by a simultaneous decrease in aggression, psychotic symptomatology, and anxiety.

Efficacy and Tolerability in Migraine Prophylaxis of Flunarizine in Reduced Doses: A Comparison with Propranolol 160 Mg Daily

Cephalalgia ◽  
2002 ◽  
Vol 22 (3) ◽  
pp. 209-221 ◽  
Author(s):  
HC Diener ◽  
J Matias-Guiu ◽  
E Hartung ◽  
V Pfaffenrath ◽  
HP Ludin ◽  
...  
Keyword(s):  
Adverse Events ◽  
Attack Frequency ◽  
Double Blind ◽  
Equivalence Trial ◽  
Treatment Groups ◽  
Equivalence Tests ◽  
Propranolol Group ◽  
The Mean ◽  
Drug Free ◽  
Better Than

This was a phase-IV double-blind equivalence trial designed to assess the efficacy and tolerability of two doses of flunarizine (10 mg o.d. = FLU 10 mg and 5 mg o.d. = FLU 5 mg) in the prophylaxis of migraine, in comparison with slow-release propranolol (160 mg o.d.). A total of 808 subjects were treated in a treatment period of 16 weeks. 142 subjects discontinued the trial prematurely, mainly because of adverse events ( n = 58). The mean attack frequency in the double-blind period was 2.0 for the FLU 5 mg group, 1.9 for the FLU 10 mg group, and 1.9 for the propranolol group. The mean attack frequency in the last 28 days of the double-blind period was 1.8 for FLU 5 mg, 1.6 for FLU 10 mg, and 1.7 for propranolol. Both flunarizine groups were at least as effective as propranolol ( P< 0.001 in one-sided test). The percentage of responders (defined as subjects for whom attack frequency decreased by at least 50% compared to run-in) in the last 28 days of the double-blind period was 46% (118/259) for FLU 5 mg, 53% (141/264) for FLU 10 mg, and 48% (125/258) for propranolol. Statistical analysis showed that FLU 10 mg is at least as effective as propranolol ( P< 0.001) and showed a trend for noninferiority of FLU5 and propranolol ( P = 0.053). No statistically significant differences between the treatment groups were found for any of the secondary parameters. Overall, 190 subjects reported one or more adverse events during the run-in phase: 54 (20.5%) in the FLU 5 mg group, 76 (27.7%) in the FLU 10 mg group and 60 (22.3%) in the propranolol group. The results of this equivalence trial show that 10 mg flunarizine daily with a drug-free weekend is at least as effective as 160 mg propranolol in the prophylaxis of migraine for all evaluated parameters (one-sided equivalence tests) after 16 weeks of treatment. In addition, 5 mg flunarizine proves to be at least as effective as 160 mg propranolol when looking at the mean attack frequency for both the whole double-blind period and the last 28 days of treatment. However, in the analysis of responders, 160 mg propranolol seems to be slightly better than 5 mg flunarizine. In addition, no significant differences between the three treatments were found with regard to safety: all three treatments were generally well-tolerated and safe.

Is There a Central Nervous Withdrawal Syndrome Associated with Discontinuing Long-term Treatment with Propranolol?

1988 ◽  
Vol 7 (3) ◽  
pp. 249-254 ◽  
Author(s):  
H. Al-Qassab ◽  
L.A. Cleeves ◽  
P.L. Francis ◽  
M.R. Al-Sereiti ◽  
L. Findley ◽  
...  
Keyword(s):  
Withdrawal Syndrome ◽  
Rating Scales ◽  
Term Treatment ◽  
Double Blind ◽  
Psychomotor Tests ◽  
Beta Adrenoceptor ◽  
Long Term Treatment ◽  
Propranolol Group ◽  
Propranolol Treatment ◽  
Long Acting

Thirty healthy volunteers were treated with beta-adrenoceptor blocking doses of long-acting propranolol for at least 28 days before being randomized to continue propranolol treatment, receive identical placebo under double-blind conditions, or discontinue all treatment. No evidence of a central nervous withdrawal syndrome occurred during the next 28 days as assessed by changes in psychomotor tests, rating scales, visual analogue scales, tremor recordings and melatonin excretion. Three subjects in the placebo withdrawal group but none in the propranolol group complained of insomnia for up to 14 days of the withdrawal period.

A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

1997 ◽  
Vol 25 (4) ◽  
pp. 175-181 ◽  
Author(s):  
H Al-Muhaimeed
Keyword(s):  
Allergic Rhinitis ◽  
Statistical Significance ◽  
Double Blind Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Once Daily ◽  
Runny Nose ◽  
Parallel Group ◽  
The Mean ◽  
To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

scholarly journals A Double-Blind Randomized Prospective Study Comparing Ondansetron with Droperidol in the Prevention of Emesis following Strabismus Surgery

1995 ◽  
Vol 23 (4) ◽  
pp. 438-443 ◽  
Author(s):  
A. Davis ◽  
S. Krige ◽  
D. Moyes
Keyword(s):  
Recovery Time ◽  
Strabismus Surgery ◽  
Double Blind Study ◽  
Double Blind ◽  
Oral Fluids ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
To Receive ◽  
Mean Time

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.

scholarly journals P277 Assessment of disease activity using RAPID3 and evaluation of treatment effect of guselkumab in patients with PsA: results from a randomised placebo-controlled Phase 2 clinical trial

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Atul Deodhar ◽  
Bruce Kirkham ◽  
Proton Rahman ◽  
Philip Helliwell ◽  
Alice B Gottlieb ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Rating Scales ◽  
Activity Index ◽  
Remission Rate ◽  
Clinical Care ◽  
Phase 2 ◽  
Study Investigator ◽  
The Mean ◽  
To Receive

Abstract Background To evaluate the effect of guselkumab (GUS) on Routine Assessment of Patient Index Data 3 (RAPID3) in patients with psoriatic arthritis (PsA). Methods In a Phase 2 trial, patients with active PsA and ≥3% body surface area of plaque psoriasis despite current or previous treatment with standard-of-care therapies, including anti-TNFα agents, were randomized 2:1 to receive GUS 100 mg (n = 100) or placebo (PBO, n = 49) subcutaneously at weeks 0, 4, and every 8 weeks (q8w) thereafter through W44. At W16, patients from either group with &lt;5% improvement from baseline in both swollen and tender joint counts were eligible for early escape to open label ustekinumab. At W24, all remaining PBO patients crossed over to receive GUS 100 mg, and then received GUS at W28 and q8w thereafter through W44. RAPID3 (0-30) is derived from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) and numerical rating scales (0-10) for pain and patient global assessment. A change of 5.1 in RAPID3 score was identified as the minimally important difference (MID) in PsA, and RAPID3 ≤3.0 was used to define PsA remission. Change in RAPID3 and proportion of patients achieving MID were compared between treatments. Correlations of RAPID3 scores with the PsA Disease Activity Score (PASDAS), GRACE index, Disease Activity in Psoriatic Arthritis (DAPSA), and Modified Composite Psoriatic Disease Activity Index (mCPDAI) were evaluated using Spearman correlation. Results The mean (SD) RAPID3 score at baseline was 16.9 (5.19). At W24, patients in the GUS group (n = 100) achieved statistically significantly greater decrease from baseline (improvement) in RAPID3 (-5.81 ± 6.0) than the PBO group (n = 49) (-0.57 ± 5.1, p &lt; 0.001), and 50% of patients in the GUS group vs 20.4% in the PBO group achieved an MID (p &lt; 0.001). Higher RAPID3 remission rate in the GUS than the PBO group (14.0% vs 2.4%, p = 0.022) was observed. The mean ± SD decrease from baseline in RAPID3 was -6.36 ± 6.2 at W24, and -7.48 ± 6.3 at W44 in those who continued GUS (n = 86). Among patients who switched from PBO to GUS at W24 (n = 28), mean ± SD change from baseline (improvement) in RAPID3 was -2.28 ± 5.2 at W24 while on placebo and -7.60 ± 6.6 at W44 after switching to GUS. The RAPID3 score was highly correlated with PASDAS (r = 0.84, p &lt; 0.001), GRACE index (r = 0.89, p &lt; 0.001), DAPSA (r = 0.77 p &lt; 0.001) and mCPDAI (r = 0.65, p &lt; 0.001) at W16. Conclusion GUS-treated PsA patients demonstrated significant improvement in RAPID3 compared to PBO. RAPID3 is simple and feasible to use in routine clinical care, and it correlates well with other comprehensive PsA-specific disease activity measures. Disclosures A. Deodhar: Other; A.D. has been a study investigator for Janssen. B. Kirkham: Other; B.K. has been a study investigator for Janssen. P. Rahman: Other; P.R. has been a study investigator for Janssen. P. Helliwell: Other; P.H. has been a study investigator for Janssen. A.B. Gottlieb: Other; A.G. has been a study investigator for Janssen. W. Boehncke: Other; W.B. has been a study investigator for Janssen. X.L. Xu: Other; X.X. is a Janssen employee. P.C. Gorecki: Other; P.G. is a Janssen employee. C. Han: Other; C.H. is a Janssen employee.

scholarly journals Effects of Rivastigmine on Memory and Cognition in Multiple Sclerosis

2008 ◽  
Vol 35 (4) ◽  
pp. 476-481 ◽  
Author(s):  
Vahid Shaygannejad ◽  
Mohsen Janghorbani ◽  
Fereshteh Ashtari ◽  
Hamid Afshar Zanjani ◽  
Naser Zakizade
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Dysfunction ◽  
Clinical Symptoms ◽  
Placebo Response ◽  
Response To Treatment ◽  
Double Blind ◽  
Wechsler Memory Scale ◽  
Memory Score ◽  
The Mean ◽  
To Receive

Background:Cognitive dysfunction is one of the common clinical symptoms in multiple sclerosis (MS), but there is no effective treatment for it.Objective:The aim of this study was to evaluate the effect of rivastigmine in treating memory and cognitive dysfunction in MS.Methods:A single-center double-blind placebo-controlled randomized clinical trial conducted from October 2005 to February 2007. Sixty definite MS patients with cognitive impairment age 16 to 54 years were randomly allocated to receive a 12-week treatment course of either rivastigmine (1.5 mg once a day increment over 4 weeks to 3 mg twice daily) or placebo. Response to treatment was assessed by the Wechsler Memory Scale (WMS) at baseline and 12 weeks after start of therapy.Results:A slight, but significant memory improvement occurred in both groups. Of the 30 patients treated with rivastigmine, the mean (SD) WMS general memory score increased from 60.3 (4.2) at baseline to 64.9 (5.3) at the end of study period (P<0.001). Correspondingly, in the 30 patients treated with placebo, the mean (SD) WMS general memory score increased from 60.5 (4.9) to 64.5 (3.7) (P < 0.001). The average WMS general memory score at the end of trial did not changed between rivastigmine and placebo group (mean difference, 0.4; 95% CI, -2.0, 2.8).Conclusion:No significant differences were seen between rivastigmine and placebo on the mean (SD) WMS general memory score. A larger multicenter study of rivastigmine in MS is warranted in order to more definitely assess the efficacy of this intervention.

The Efficacy of N-acetilcysteine for the Treatment of the Metamfetamin-addicted Patients Under Methadon Therapy: A Double-blind Clinical Trial

2020 ◽  
Vol 22 (7) ◽  
Author(s):  
Farzaneh Karami ◽  
Fateme Assarian ◽  
Fatemeh Sadat Ghoreishi ◽  
Mojtaba Sehat
Keyword(s):  
Methadone Treatment ◽  
Severity Index ◽  
Addiction Severity Index ◽  
Double Blind ◽  
Addiction Severity ◽  
Methamphetamine Dependence ◽  
Double Blind Clinical Trial ◽  
The Mean ◽  
To Receive ◽  
The Brain

Background: Methamphetamine dependence is a growing global problem. Currently, there are no approved pharmacotherapy options for the management of methamphetamine dependence. One of the alternatives to manage this addiction is the use of N acetylcysteine (NAC) due to its capacity to restore homeostasis in the brain glutamate systems disrupted in addiction and its ability to reduce craving and the risk of relapse. Methods: Methamphetamine‐dependent volunteers under methadone treatment (n = 38) were randomized to receive daily doses of 1200 mg of NAC, or placebo. The participants were followed for 12 weeks (two visits weekly). Craving and Beck Inventory Depression (BDI) was determined at the beginning of the study and also after one month, two months, and three months. Addiction severity index (ASI) was recorded at the beginning of the study and after three months. The data were analyzed via SPSS version 16.0 (SPSS Inc. Chicago, Illinios, USA) Results: The mean score of craving and BDI reduced after two months with NAC treatment. ASI (e.g., substance, familial, and psychiatric categories) was significantly reduced at the end of the study in the NAC group compared to placebo (P < 0.001). The success of the treatment in groups of NAC and placebo were 84% and 73%, respectively (P = 0.001). 63.2% of the NAC group patients avoided substance use for more than a month, but this was 10.5% in the placebo group (P = 0.001). Conclusions: The NAC showed good efficacy in suppressing methamphetamine craving, addiction severity index, and depression. It may be a useful pharmacological treatment for methamphetamine dependency.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

Treatment of neuroleptic-induced akathisia with the 5-HT2 antagonist mianserin

1999 ◽  
Vol 174 (3) ◽  
pp. 238-242 ◽  
Author(s):  
Michael Poyurovsky ◽  
Marina Shardorodsky ◽  
Camil Fuchs ◽  
Michael Schneidman ◽  
Abraham Weizman
Keyword(s):  
Placebo Group ◽  
Low Dose ◽  
Rating Scales ◽  
Therapeutic Option ◽  
Response To Treatment ◽  
Double Blind ◽  
Log Odds ◽  
Double Blind Design ◽  
To Receive ◽  
Barnes Akathisia Scale

BackgroundSerotonin (5-HT): dopamine imbalance may underlie neuroleptic-induced akathisia.AimTo evaluate the efficacy of the 5-HT2 antagonist, mianserin in neuroleptic-induced akathisia.MethodsThirty neuroleptic-treated patients with schizophrenia were randomly allocated in a double-blind design to receive either mianserin (15 mg/day) or placebo for five days. Patients were assessed at baseline and on Days 3 and 5 by the Barnes Akathisia Scale (BARS), as well as by other relevant clinical rating scales.ResultsCompared with the placebo group, the mianserin-treated patients showed a significant reduction in all four BARS subscales by Day 5, with mean reductions in the BARS global score of 9.9% and 52.2%, respectively (P=0.006). Response to treatment (a reduction of at least two points on the BARS global subscale), was noted in six patients (40%) in the mianserin group and only one patient (9.1%) in the placebo group (P=0.04, log odds ratio 2.23).ConclusionsMianserin at a low dose may be a promising therapeutic option for patients with acute neuroleptic-induced akathisia.

A Comparison of Loratadine, a New Nonsedating Antihistamine, with Clemastine and Placebo in Patients with Fall Seasonal Allergic Rhinitis

1987 ◽  
Vol 1 (3) ◽  
pp. 151-154 ◽  
Author(s):  
James P. Kemp ◽  
Sami L. Bahna ◽  
Paul Chervinsky ◽  
Gary S. Rachelefsky ◽  
James M. Seltzer ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Parallel Study ◽  
Double Blind ◽  
Daily Diaries ◽  
Ocular Symptoms ◽  
Symptom Scores ◽  
The Mean ◽  
Long Acting ◽  
To Receive

Loratadine is a new nonsedating long-acting H1-antagonist which has been shown to be effective at various doses in controlling symptoms of spring seasonal allergic rhinitis. In this multicenter, double-blind, parallel study, 313 adolescent and adult patients with moderate to severe, skin-test positive, fall seasonal rhinitis were randomized to receive either loratadine, 10 mg, in the morning and placebo in the evening, clemastine 1 mg. b.i.d., or placebo b.i.d. for 2 weeks. Patients maintained daily diaries of nasal and ocular symptoms and of adverse effects. They were evaluated before and 7 and 14 days after starting treatment. The mean symptom scores on days 7 and 14 showed greater improvement with both loratadine and clemastine treatments than with placebo. The incidence of somnolence in the loratadine group by comparison with the placebo group was not statistically different, whereas clemastine caused significantly more drowsiness than did placebo. We conclude that loratadine, 10 mg, once a day is as effective as clemastine b.i.d. in decreasing the symptoms of fall seasonal rhinitis and the incidence of somnolence with loratadine is not statistically different from that with placebo.

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