Efficacy and side effect profile of olanzapine versus haloperidol for symptoms of delirium in hospitalized patients with advanced cancer: A multicenter, investigator-blinded, randomized, controlled trial (RCT).

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 231-231
Author(s):  
Maurice Van Der Vorst ◽  
Elisabeth C.W. Neefjes ◽  
Manon S.A. Boddaert ◽  
Bertha A.T.T. Verdegaal ◽  
Aart Beeker ◽  
...  
Keyword(s):  
Side Effects ◽  
Advanced Cancer ◽  
Side Effect ◽  
Rating Scale ◽  
Controlled Trial ◽  
Hospitalized Patients ◽  
Phase Iii ◽  
Side Effect Profile ◽  
Advanced Cancer Patients ◽  
Grade 3

231 Background: Delirium is highly prevalent in patients with advanced cancer. Patients experiencing delirium may require pharmacological treatment to reduce distressing symptoms. Atypical antipsychotics, like olanzapine, are potentially safer and more effective than haloperidol, but no phase III RCTs are reported in patients with advanced cancer. Methods: Hospitalized patients with advanced cancer diagnosed with delirium ( DSM-IV-TR criteria) were randomly assigned centrally (1:1) to olanzapine or haloperidol. Dosages were up-titrated. Primary endpoint was delirium resolution rate (DRR), defined as Delirium Rating Scale-Revised-98 (DRS-R-98) total severity score < 15.25 points and ≥ 4.5 points reduction. Secondary endpoints: time to recovery, grade ≥ 3 side effects (Common Terminology Criteria for Adverse Events version 3.0), and distress (Delirium Experience Questionnaire). The study was powered to increase DRR with 25% for olanzapine compared to haloperidol. Results: Between January 2010 and June 2016, 100 of the anticipated 200 patients were enrolled in the study from 6 sites in the Netherlands and randomly assigned to olanzapine (n = 50) or haloperidol (n = 50). Baseline characteristics were well balanced. Interim analysis showed a difference in DRR of -12.2% (95% confidence interval (CI) = -32.0%- 7.4%); 45% for olanzapine (95% CI 31.0-58.8) vs 57% for haloperidol (95% CI 43.3-71.0), P = 0.22).Time to recovery was 4.5 days in the olanzapine arm vs 2.8 days in the haloperidol arm (P = 0.20). There was no difference in grade ≥ 3 side effects between both arms (OR 0.44, 95% CI 0.14-1.40; P = 0.16). Mean level of distress in patients was 2.1 (SD 1.4) for olanzapine vs 2.3 (SD 1.4) for haloperidol (P = 0.80). Formal interim futility analysis indicated a conditional power of 0.086, implying a very low likelihood (8.6%) of reaching the expected DRR superiority rate of 25% for olanzapine. Therefore, the study was prematurely terminated. Conclusions: No difference in efficacy and side effect profile was observed between haloperidol or olanzapine treatment for delirium in patients with advanced cancer. Clinical trial information: NCT01539733.

scholarly journals A randomised, double blind, placebo-controlled trial of megestrol acetate or dexamethasone in treating symptomatic anorexia in people with advanced cancer

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
David C. Currow ◽  
Paul Glare ◽  
Sandra Louw ◽  
Peter Martin ◽  
Katherine Clark ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Rating Scale ◽  
Controlled Trial ◽  
Performance Status ◽  
Numeric Rating Scale ◽  
Megestrol Acetate ◽  
Phase Iii ◽  
Fixed Dose ◽  
Double Blind ◽  
Clinical Trials Registry

AbstractThis multi-site, double blind, parallel arm, fixed dose, randomised placebo controlled phase III study compared megestrol acetate 480 mg/day with dexamethasone 4 mg/day for their net effects on appetite in people with cancer anorexia. Patients with advanced cancer and anorexia for ≥ 2 weeks with a score ≤ 4 (0–10 numeric rating scale (NRS) 0 = no appetite, 10 = best possible appetite) were recruited. Participants received megestrol 480 mg or dexamethasone 4 mg or placebo daily for up to 4 weeks. Primary outcomes were at day 7. Responders were defined as having a ≥ 25% improvement in NRS over baseline. There were 190 people randomised (megestrol acetate n = 61; dexamethasone n = 67, placebo n = 62). At week 1 (primary endpoint), 79·3% in the megestrol group, 65·5% in the dexamethasone group and 58·5% in the placebo group (p = 0.067) were responders. No differences in performance status or quality of life were reported. Treatment emergent adverse events were frequent (90·4% of participants), and included altered mood and insomnia. Hyperglycemia and deep vein thromboses were more frequent when on dexamethasone than the other two arms. There was no difference in groups between the three arms, with no benefit seen over placebo with anorexia improving in all arms.Trail registration: The trial was registered on 19/08/2008 with the Australian New Zealand Clinical Trials Registry (ACTRN12608000405314).

scholarly journals Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Statistical Power ◽  
Controlled Trial ◽  
Treatment Options ◽  
Cognitive Remediation ◽  
Negative Effects ◽  
Metacognitive Training ◽  
To Receive

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

“The surprise questions” using variable time frames in hospitalized patients with advanced cancer

2021 ◽  
pp. 1-5
Author(s):  
Sun Hyun Kim ◽  
Sang-Yeon Suh ◽  
Seok Joon Yoon ◽  
Jeanno Park ◽  
Yu Jung Kim ◽  
...  
Keyword(s):  
Palliative Care ◽  
Advanced Cancer ◽  
Time Frame ◽  
Hospitalized Patients ◽  
Advanced Cancer Patients ◽  
Multicenter Cohort Study ◽  
Prediction Of Survival ◽  
Sensitivity Specificity ◽  
Surprise Question ◽  
Time Frames

Abstract Objective Several studies supported the usefulness of “the surprise question” in terms of 1-year mortality of patients. “The surprise question” requires a “Yes” or “No” answer to the question “Would I be surprised if this patient died in [specific time frame].” However, the 1-year time frame is often too long for advanced cancer patients seen by palliative care personnel. “The surprise question” with shorter time frames is needed for decision making. We examined the accuracy of “the surprise question” for 7-day, 21-day, and 42-day survival in hospitalized patients admitted to palliative care units (PCUs). Method This was a prospective multicenter cohort study of 130 adult patients with advanced cancer admitted to 7 hospital-based PCUs in South Korea. The accuracy of “the surprise question” was compared with that of the temporal question for clinician's prediction of survival. Results We analyzed 130 inpatients who died in PCUs during the study period. The median survival was 21.0 days. The sensitivity, specificity, and overall accuracy for the 7-day “the surprise question” were 46.7, 88.7, and 83.9%, respectively. The sensitivity, specificity, and overall accuracy for the 7-day temporal question were 6.7, 98.3, and 87.7%, respectively. The c-indices of the 7-day “the surprise question” and 7-day temporal question were 0.662 (95% CI: 0.539–0.785) and 0.521 (95% CI: 0.464–0.579), respectively. The c-indices of the 42-day “the surprise question” and 42-day temporal question were 0.554 (95% CI: 0.509–0.599) and 0.616 (95% CI: 0.569–0.663), respectively. Significance of results Surprisingly, “the surprise questions” and temporal questions had similar accuracies. The high specificities for the 7-day “the surprise question” and 7- and 21-day temporal question suggest they may be useful to rule in death if positive.

scholarly journals Suvorexant: A boon for Sleepless Nights

2016 ◽  
Vol 14 (1) ◽  
pp. 43-45
Author(s):  
Anjan Khadka ◽  
Dick Brashier ◽  
Amol Vijay Khanpure ◽  
Pem Chuki
Keyword(s):  
General Practice ◽  
Side Effects ◽  
Side Effect ◽  
Sleep Onset ◽  
Side Effect Profile ◽  
New Class ◽  
Sleep Maintenance ◽  
Nonrestorative Sleep ◽  
Arousal System ◽  
Falling Asleep

Insomnia is characterized by difficulty in falling asleep, difficulty maintaining sleep, or experiencing nonrestorative sleep. Insomnia is the most common medical complaint in general practice.  Low efficacy and various side effects limit the use of existing treatment option. Suvorexant is an orexin receptor antagonist (ORA), first in a new class of drugs in development for the treatment of insomnia. It inhibits the wakefulness-promoting orexin neurons of the arousal system thereby promoting the natural transition from wakefulness. It also improves sleep onset and sleep maintenance and has a favorable tolerability and limited side-effect profile.

Proposed trial: safety and efficacy of resveratrol for the treatment of non-alcoholic fatty liver disease (NAFLD) and associated insulin resistance in adolescents who are overweight or obese adolescents — rationale and protocol

2015 ◽  
Vol 93 (5) ◽  
pp. 522-530 ◽  
Author(s):  
Brandy Wicklow ◽  
Kristy Wittmeier ◽  
Geert W. t’ Jong ◽  
Jonathon McGavock ◽  
Marni Robert ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Fatty Liver ◽  
Outcome Measures ◽  
Side Effect ◽  
Controlled Trial ◽  
Whole Body ◽  
Secondary Outcome ◽  
Side Effect Profile ◽  
Obese Adolescent ◽  
Alcoholic Fatty Liver

Non-alcoholic fatty liver (NAFL) disease (NAFLD) affects 30% of overweight adolescents and increases the risk of type 2 diabetes mellitus (T2D). Resveratrol is a naturally occurring compound with potential to reverse NAFL and its associated insulin resistance in adults. The use of resveratrol to reduce risk for T2D through its effect on NAFL has not been examined to date in youth. This paper provides a literature review and protocol for a 30 day proof of principle trial of resveratrol in a population of adolescents at risk for T2D. This randomized double-blind controlled trial is designed with the primary objective of evaluating a twice daily supplementation of 75 mg of resveratrol for safety and tolerability in overweight and obese adolescent subjects (13 to <18 years of age) with NAFL. Secondary objectives are to determine the effect size of the intervention on hepatic steatosis and whole body insulin sensitivity. Adolescents in the intervention arm (n = 10) will receive oral supplementation of resveratrol 75 mg twice daily (with breakfast and dinner) for a total daily dose of 150 mg for the duration of 30 days. The comparison group (n = 10) will receive a placebo twice daily for 30 days. Both cases and controls will receive a standardized lifestyle intervention program. Subjects in both groups will be followed for an additional 30 days post intervention for total study duration of approximately 60 days. Primary outcome measures include a primary side effect profile determined by participant interview, a side effect profile determined by serum biochemistry and vital signs. Secondary outcome measures include an oral glucose tolerance test, liver and cardiac fat content measured by magnetic resonance spectroscopy, anthropometric measures of overweight/obesity, inflammatory markers, and cardiac function and morphology measured with ultrasonography. Additional outcome measures include serum concentrations of resveratrol, compliance to protocol, physical activity, and nutritional assessment. This study will determine the safety and tolerability of resveratrol in an overweight adolescent population and inform the design of a larger randomized controlled trial.

Syndrome of Inappropriate Antidiuretic Hormone Associated with Escitalopram Therapy

CNS Spectrums ◽  
2006 ◽  
Vol 11 (6) ◽  
pp. 429-432 ◽  
Author(s):  
Anjali Nirmalani ◽  
Saundra L. Stock ◽  
Glenn Catalano
Keyword(s):  
United States ◽  
Side Effects ◽  
High Risk ◽  
Antidiuretic Hormone ◽  
Side Effect ◽  
Parent Compound ◽  
The United States ◽  
Side Effect Profile ◽  
Significant Side Effect ◽  
Risk Patients

ABSTRACTEscitalopram is the selective serotonin reuptake inhibitor (SSRI) most recently approved for use in the United States. It is structurally related to citalopram, but is felt to have a more tolerable side-effect profile than its parent compound. Side effects are not generally serious and include headache, diarrhea, and nausea. While hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) have been associated with treatment with other SSRIs, there has only been one case of escitalopram-induced SIADH reported in the literature to date. We now report another case of a patient who developed SIADH after being treated with escitalopram for 4 weeks. The patient's hyponatremia improved following the discontinuation of escitalopram. Clinicians should be aware of this uncommon but significant side effect of SSRIs and monitor high-risk patients for the development of SIADH.

The Science of Antipsychotics: Mechanistic Insight

CNS Spectrums ◽  
2003 ◽  
Vol 8 (S2) ◽  
pp. 5-9 ◽  
Author(s):  
Carol A. Tamminga
Keyword(s):  
Side Effects ◽  
Tardive Dyskinesia ◽  
Side Effect ◽  
Negative Symptoms ◽  
New Drugs ◽  
Receptor Subtypes ◽  
Side Effect Profile ◽  
Cognitive Symptoms ◽  
Conventional Antipsychotics ◽  
New Antipsychotics

ABSTRACTWith the introduction of conventional antipsychotics in the 1950s, clinicians began to expect effective treatment of positive symptoms of schizophrenia. However, these drugs do not resolve negative and cognitive symptoms of schizophrenia and are also associated with serious side effects, including extrapyramidal side effects (EPS) and tardive dyskinesia. In 1989, clozapine was introduced and labeled the first new antipsychotic owing to its improved efficacy and side-effect profile. Clozapine proved effective in alleviating many of the positive, negative, and cognitive symptoms of schizophrenia, without causing inevitable EPS or tardive dyskinesia. Over the past decade, a number of different new antipsychotics have been developed. These drugs have an affinity for multiple dopamine-receptor subtypes as well as serotonin, norepinephrine, and glutamate receptors, allowing for better treatment outcomes. The antagonism of the 5-HT2A receptor may be responsible for improvement in negative symptoms and decrease in EPS. In addition to providing enhanced efficacy, the affinity of the new drugs for multiple receptors introduces new side effects not seen with the conventional agents, including weight gain. Each new antipsychotic has a unique receptor-binding profile that corresponds to its pharmacologic and side-effect profile. Understanding the differences in mechanisms of action of new antipsychotics will allow physicians to better choose treatment that meets the needs of each individual patient.

High Familial Correlation in Methylphenidate Response and Side Effect Profile

2015 ◽  
Vol 23 (2) ◽  
pp. 135-139 ◽  
Author(s):  
Michal Gazer-Snitovsky ◽  
Ayelet Brand-Gothelf ◽  
Gal Dubnov-Raz ◽  
Abraham Weizman ◽  
Doron Gothelf
Keyword(s):  
Side Effect ◽  
Rating Scale ◽  
Immediate Release ◽  
Familial Correlation ◽  
Side Effect Profile ◽  
Emotional Symptoms ◽  
Clinical Global Impression Scale ◽  
Intraclass Correlations ◽  
History Of ◽  
Loss Of Appetite

Objective: To examine whether a familial tendency exists in clinical response to methylphenidate. Method: Nineteen pairs of siblings or parent–child stimulant-naive individuals with ADHD were prescribed methylphenidate–immediate release, and were comprehensively evaluated at baseline, Week 2, and Week 4, using the ADHD Rating Scale IV, Clinical Global Impression Scale, and the Barkley Side Effects Rating Scale. Results: We found significant intraclass correlations in family member response to methylphenidate–immediate release and side effect profile, including emotional symptoms and loss of appetite and weight. Conclusion: Family history of response to methylphenidate should be taken into account when treating ADHD.

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