Randomised double-blind comparison of the incidence of tardive dyskinesia in patients with schizophrenia during long-term treatment with olanzapine or haloperidol

1999 ◽  
Vol 174 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Charles M. Beasley ◽  
Mary Anne Dellva ◽  
Roy N. Tamura ◽  
Hal Morgenstern ◽  
William M. Glazer ◽  
...  
Keyword(s):  
Relative Risk ◽  
Tardive Dyskinesia ◽  
Incidence Rate ◽  
Involuntary Movement ◽  
Term Treatment ◽  
Double Blind ◽  
Long Term Treatment ◽  
Blind Comparison ◽  
One Year

BackgroundTardive dyskinesia is important in the side-effect profile of antipsychotic medication.AimsThe development of tardive dyskinesia was evaluated in patients treated with double-blind, randomly assigned olanzapine or haloperidol for up to 2.6 years.MethodsTardive dyskinesia was assessed by the Abnormal Involuntary Movement Scale (AIMS) and Research Diagnostic Criteria for Tardive Dyskinesia (RD-TD); it was defined as meeting RD-TD criteria at two consecutive assessments. The risk of tardive dyskinesia, the relative risk, incidence rate, and incidence rate ratio were estimated.ResultsThe relative risk of tardive dyskinesia for the overall follow-up period for haloperidol (n=522) v. olanzapine (n=1192) was 2.66 (95% CI=1.50–4.70). Based on data following the initial six weeks of observation (during which patients underwent medication change and AIMS assessments as frequently as every three days), the one-year risk was 0.52% with olanzapine (n=513) and 7.45% with haloperidol (n=114). The relative risk throughout this follow-up period was 11.37 (95% Cl=2.21–58.60).ConclusionOur results indicated a significantly lower risk of tardive dyskinesia with olanzapine than with haloperidol.

scholarly journals 139 Early Response with Valbenazine and Long-Term Symptom Reduction in Patients with Tardive Dyskinesia: Post Hoc Analysis of the KINECT 3 Study

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 288-289
Author(s):  
Stanley N. Caroff ◽  
Jean-Pierre Lindenmayer ◽  
Stephen R. Marder ◽  
Stewart A. Factor ◽  
Khodayar Farahmand ◽  
...  
Keyword(s):  
Tardive Dyskinesia ◽  
Early Response ◽  
Term Treatment ◽  
Score Change ◽  
Double Blind ◽  
Early Improvement ◽  
Long Term Treatment ◽  
Post Hoc ◽  
Improvement Score

Abstract:Study Objective:Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with prolonged exposure to antipsychotics and other dopamine receptor blocking agents. Valbenazine is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of TD in adults. Using data from a long-term study (KINECT 3; NCT02274558), the effects of once-daily valbenazine (40 mg, 80 mg) on TD were assessed using the Abnormal Involuntary Movement Scale (AIMS) in participants who were early responders based on subjective measures, including patient self-report (Patient Global Impression of Change [PGIC]) or clinician judgment (Clinical Impression of Change-Tardive Dyskinesia [CGI-TD]).Methods:Data from KINECT 3 (6-week double-blind, placebo-controlled [DBPC] period; 42-week double-blind extension) were analyzed post hoc. Long-term outcomes included mean change from baseline to Week 48 in AIMS total score (sum of items 1-7) and AIMS response (≥50% total score improvement from baseline) at Week 48. These AIMS outcomes were assessed in participants who achieved early improvement, defined as a PGIC or CGI-TD score of ≤3 (“minimally improved” or better) at Week 2 (first post-baseline visit of the DBPC period). Participants who initially received placebo were not included in the analyses.Results:In participants who received only valbenazine (40 or 80 mg) during KINECT 3 and had available Week 2 assessment, 50% (72/143) had early PGIC improvement (score ≤3) and 43% (61/142) had early CGI-TD improvement (score ≤3). Baseline characteristics were generally similar between participants who achieved early PGIC or CGI-TD improvement and those who did not. Based on available assessments at Week 48, mean AIMS total score change from baseline in participants with early PGIC improvement was similar to those who did not reach the early PGIC improvement threshold (-4.1 [n=35] vs -3.5 [n=41]). Mean AIMS total score change from baseline in participants with early CGI-TD improvement was similar to those who did not achieve early CGI-TD improvement (-4.2 [n=31] vs -3.5 [n=45]). AIMS response at Week 48 was also similar in those who achieved early PGIC and CGI-TD improvement (40% and 42%, respectively) compared to those who did not achieve early PGIC and CGI-TD improvement (39% and 38%, respectively).Conclusions:Results from this long-term valbenazine trial indicate that many participants achieved at least minimal patient- and clinician-reported improvement at Week 2. AIMS outcomes at Week 48 demonstrated long-term reductions in TD severity regardless of early response. More research is needed to understand the association between early improvement and long-term treatment effects, but early non-improvement based on subjective measures may not be predictive of long-term treatment failure.Presented:International Congress of Parkinson’s Disease and Movement Disorders; September 22-26, 2019; Nice, France.Funding Acknowledgements:This study was sponsored by Neurocrine Biosciences, Inc.

Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study

2009 ◽  
Vol 92 (3) ◽  
pp. S107 ◽  
Author(s):  
C. Seitz ◽  
C. Gerlinger ◽  
T. Faustmann ◽  
T. Strowitzki
Keyword(s):  
Term Treatment ◽  
Open Label ◽  
Follow Up Study ◽  
Long Term Treatment ◽  
One Year

scholarly journals Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
David H. Adams ◽  
Lu Zhang ◽  
Brian A. Millen ◽  
Bruce J. Kinon ◽  
Juan-Carlos Gomez
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Term Treatment ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Treatment Groups ◽  
Long Term Treatment ◽  
Blind Comparison

We tested the hypothesis that long-term treatment with pomaglumetad methionil would demonstrate significantly less weight gain than aripiprazole in patients with schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 3 study, 678 schizophrenia patients were randomized to either pomaglumetad methionil (n=516) or aripiprazole (n=162). Treatment groups were also compared on efficacy and various safety measures, including serious adverse events (SAEs), discontinuation due to adverse events (AEs), treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), and suicide-related thoughts and behaviors. The pomaglumetad methionil group showed significantly greater weight loss at Week 24 (Visit 12) compared with the aripiprazole group (−2.8 ± 0.4 versus 0.4 ± 0.6;P<0.001). However, change in Positive and Negative Syndrome Scale (PANSS) total scores for aripiprazole was significantly greater than for pomaglumetad methionil (−15.58 ± 1.58 versus −12.03 ± 0.99;P=0.045). The incidences of SAEs (8.2% versus 3.1%;P=0.032) and discontinuation due to AEs (16.2% versus 8.7%;P=0.020) were significantly higher for pomaglumetad methionil compared with aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with pomaglumetad methionil resulted in significantly less weight gain than aripiprazole. This trial is registered with ClinicalTrials.govNCT01328093.

scholarly journals Long-term effectiveness and prediction of treatment outcome in cognitive behavioral therapy and sertraline for late-life anxiety disorders

2009 ◽  
Vol 21 (6) ◽  
pp. 1148-1159 ◽  
Author(s):  
Josien Schuurmans ◽  
Hannie Comijs ◽  
Paul M. G. Emmelkamp ◽  
Ingrid J. C. Weijnen ◽  
Marcel van den Hout ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Anxiety Disorders ◽  
Behavioral Therapy ◽  
Late Life ◽  
Term Treatment ◽  
Short Term ◽  
Long Term Treatment ◽  
One Year

ABSTRACTBackground: Although anxiety disorders are prevalent in older adults, randomized controlled trials of treatment effectiveness for late-life anxiety are scarce and have focused primarily on the effectiveness of psychotherapeutic interventions. However, recent findings suggest that in some cases, pharmacological treatment may be more beneficial for late-life anxiety disorders. As yet, there have been no systematic studies investigating prognostic factors for the outcome of cognitive behavioral therapy (CBT) and pharmacotherapy for late-life anxiety. The objective of the present study was to study long-term treatment outcomes and to explore differential predictors for both short-term and long-term treatment outcomes of sertraline and CBT for late-life anxiety disorders.Methods: Participants of a randomized controlled trial (RCT) comparing sertraline and CBT for the treatment of late-life anxiety were contacted one year after completing their treatment, so that predictors for both short-term and long-term treatment outcome could be established.Results: Sertraline showed a greater reduction of symptoms than CBT on anxiety (Hamilton Anxiety Rating Scale; HARS) and worry (Worry Domain Questionnaire) ratings at one-year follow-up. The strongest predictor for short-term CBT outcome was poor perceived health, explaining 40% of the variance in post-treatment residual gain scores on the HARS. The strongest predictor for long-term CBT outcome was neuroticism, explaining 20% of the variance in residual gain scores at one-year follow-up. Analyses revealed no significant predictors for treatment outcome in sertraline participants.Conclusions: Our study suggests that long-term use of sertraline might be more beneficial for late-life anxiety than a 15-week CBT program. Poor perceived health and neuroticism are predictive of less improvement after CBT in anxious older adults. Implications of these findings are discussed.

The Safety of Fluoxetine - An Update

1988 ◽  
Vol 153 (S3) ◽  
pp. 77-86 ◽  
Author(s):  
Glenn L. Cooper
Keyword(s):  
Tricyclic Antidepressants ◽  
Term Treatment ◽  
Major Depressive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
The Core ◽  
Antidepressant Agent ◽  
Long Term Treatment ◽  
One Year

Fluoxetine is a new antidepressant agent which is a selective inhibitor of neuronal serotonin uptake; it has minimal affinity for muscarinic, dopaminergic, histaminic, serotonergic, or noradrenergic receptors (Stark et al, 1985). This specificity of activity suggests that fluoxetine may have a side-effect profile which is different from previously available antidepressants.The safety of fluoxetine has been extensively studied: several hundred patients have received the drug continuously for more than one year - some have had therapy for 5 years or more. Previous reviews of the safety of fluoxetine (Wernicke, 1985; Zerbe, 1986) have described a smaller population of patients than is now available.This review is drawn from data pooled from comparative clinical trials, which included 4336 patients: fluoxetine - 2938, tricyclic antidepressants (TCAs) - 599, and placebo - 799 patients. The TCAs studied were amitriptyline, imipramine, and doxepin. Most patients were adults with major depressive disorder, and the most common study design was a 6-week comparative double-blind phase, followed by unblinded long-term treatment. While the core of this study is a data base of 2938 fluoxetine-treated patients, all serious adverse events reported in over 7500 fluoxetine-treated patients worldwide, as of mid-1987, have been included.

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