scholarly journals Long-term safety and tolerability of asenapine: A double-blind, uncontrolled, long-term extension trial in adults with an acute manic or mixed episode associated with bipolar I disorder

2017 ◽  
Vol 207 ◽  
pp. 384-392 ◽  
Author(s):  
Terence A. Ketter ◽  
Suresh Durgam ◽  
Ronald Landbloom ◽  
Mary Mackle ◽  
Xiao Wu ◽  
...  
Keyword(s):  
Double Blind ◽  
Mixed Episode ◽  
Bipolar I Disorder ◽  
Extension Trial

P01-226-Line item analysis in paediatric patients with bipolar I disorder treated with aripiprazole

2011 ◽  
Vol 26 (S2) ◽  
pp. 227-227
Author(s):  
J.-Y. Loze ◽  
R. Mankoski ◽  
J. Zhao ◽  
W. Carson ◽  
E. Youngstrom ◽  
...  
Keyword(s):  
Rating Scale ◽  
Speech Rate ◽  
Randomised Trial ◽  
High Energy ◽  
Young Mania ◽  
Double Blind ◽  
General Behaviour ◽  
Mixed Episode ◽  
Bipolar I Disorder ◽  
Paediatric Patients

IntroductionAripiprazole has demonstrated efficacy for the treatment of paediatric patients (10–17 years) with a manic or mixed episode associated with bipolar I disorder in a clinical trial that utilised the Young Mania Rating Scale (YMRS) Total score as the primary outcome measure.Objectives/aimThis analysis evaluated the profile of discrete symptom response using the YMRS and other measures.MethodsPost-hoc analysis of individual items of the YMRS and the parent or subject version of the General Behaviour Inventory (GBI) Mania and Depression scales using data from a 4-week, double-blind, randomised trial that compared aripiprazole (10 or 30 mg/day, n = 197) with placebo (n = 99).ResultsIn total, 296 patients were randomised; 80% completed the study. Significant decreases at Week 4 (p < 0.05) were seen in eight YMRS items: elevated mood, increased motor activity/energy, need for sleep, irritability, speech (rate and amount), language/thought disorder, abnormal thought content and disruptive/aggressive behaviour. For the GBI, effect sizes for parent-reported mania items were medium to large (for example, 0.41 for ‘depressed but high energy’ to 0.78 for ‘rage combined with unusually happy’) but were consistently small on subject self-reported items of mania and depression and, for the overall scale, had the poorest agreement with clinician ratings.ConclusionsAripiprazole demonstrated improvements in some of the more troublesome symptoms of paediatric patients with bipolar I disorder experiencing an acute manic or mixed episode. Of note, irritability and aggression showed large treatment effects on both clinician and parent-reported measures, but less so for subject-reported measures.

Efficacy of adjunctive aripiprazole to lithium or valproate in the long-term treatment of mania in subjects with bipolar i disorder (CN138–189)

2011 ◽  
Vol 26 (S2) ◽  
pp. 186-186 ◽  
Author(s):  
M. Abbar ◽  
A. Khan ◽  
L. Rollin ◽  
R. Sanchez ◽  
W. Carson ◽  
...  
Keyword(s):  
Severity Of Illness ◽  
Term Treatment ◽  
Sustained Remission ◽  
Mood Stabiliser ◽  
Double Blind ◽  
Bipolar I Disorder ◽  
Long Term Treatment ◽  
Significant Difference ◽  
Time To Relapse

ObjectivesTo evaluate the long-term safety and efficacy of adjunctive aripiprazole (ARI) to lithium (LI) or valproate (VAL) in delaying time to relapse in bipolar I disorder.MethodsBipolar I disorder subjects with a current manic or mixed episode received LI or VAL for at least 2 weeks; inadequate responders (YMRS score ≥ 16 and ≤35% decrease from baseline at 2 weeks) received adjunctive ARI. Subjects maintaining mood stability (YMRS and MADRS ≤ 12 for 12 consecutive weeks) were randomised 1:1 to double-blind ARI (10 to 30 mg/day) or placebo (PBO) plus LI or VAL. Relapse was monitored up to 52 weeks.Results337 subjects were randomised to continuation of mood stabiliser plus adjunctive ARI or PBO; 61.3% and 52.7%, respectively, completed the study. Adjunctive ARI significantly delayed the time to any relapse, hazard ratio = 0.544 (95% CI: 0.33, 0.89, log-rank p = 0.014). Overall relapse rates at 52 weeks were 14.9% and 25.4% in ARI vs PBO subjects. A superior reduction in CGI-BP Mania Severity of Illness from baseline at 52 weeks was also observed (0.3 vs. 0.0, respectively, p = 0.01). Adverse events generally were as expected per known drug and illness profiles with no significant difference in mean change in body weight between adjunctive PBO (0.60 kg) and adjunctive ARI (1.07 kg) (p = 0.49 Week 52, LOCF).ConclusionContinuation of aripiprazole treatment increased time to relapse to any mood episode compared with placebo plus LI/VAL over 1 year, indicating a long-term benefit in continuing adjunctive aripiprazole to a mood stabiliser after sustained remission is achieved.

A Double-Blind, Placebo-controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
J. Houston ◽  
M. Tohen ◽  
E. Degenhardt ◽  
H. Jamal ◽  
L. Liu ◽  
...  
Keyword(s):  
Rating Scale ◽  
Controlled Trial ◽  
Blood Levels ◽  
Young Mania ◽  
Double Blind ◽  
Mixed Episode ◽  
Bipolar I Disorder ◽  
Double Blind Placebo ◽  
Concomitant Medications ◽  
Unique Study

Aims:This unique study of treatment of the mixed state of bipolar I disorder using simultaneous depression and mania response criteria compared divalproex monotherapy versus olanzapine augmentation in a 6-week, randomized, double-blind trial.Methods:Patients (age 18-60 years) with 14-28 days of divalproex monotherapy (blood levels of 75-125 μg/mL) were randomized to augmentation with olanzapine 5-20 mg/day or placebo. Data collected included: Hamilton Depression Rating Scale (HDRS), Young Mania Rating Scale (YMRS), Clinical Global Impression for Bipolar Illness (CGI-BP), hospitalizations, concomitant medications, and adverse events (AEs). Primary co-objectives were comparisons of baseline to endpoint changes in HDRS and YMRS. Secondary objectives included comparisons of times to onset (25% reduction) and response (50% reduction) in both HDRS and YMRS, change in CGI-BP, hospitalizations, and safety.Results:Patients were 59% female, 51% Caucasian, 33% African American, and 14% Hispanic with mean standard deviation (SD) HDRS and YMRS scores of 22.2 (4.5) and 20.9 (4.4). Mean standard error (SE) score changes for the olanzapine (n=100) or placebo (n=101) arms, respectively, were: HDRS, -9.37 (.55) and -7.69 (.54), p=.022; YMRS, -10.15 (.44) and -7.68 (.44), p< .001; and CGI-BP, -1.34 (.11) and -1.06 (.11), p=.056. Times-to-onset (median 7 vs 14 days) and response (median 25 vs 49 days) were significantly shorter for olanzapine augmentation. One olanzapine patient required hospitalization (p=1.0). Treatment-emergent AEs were consistent with previously-published rates.Conclusion:Six-week olanzapine treatment augmentation was associated with greater and earlier reduction of manic and depressive symptoms in mixed episode patients on divalproex treatment.

The Evaluation of Long-Term Ferumoxytol Use as An Iron Replacement Therapy In Patients with Iron Deficiency Anemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5156-5156
Author(s):  
Allen Poma ◽  
Karen Diana ◽  
Justin McLaughlin ◽  
Annamaria Kausz
Keyword(s):  
Iron Deficiency ◽  
Blood Loss ◽  
Deficiency Anemia ◽  
Double Blind ◽  
Patient Reported ◽  
The Us ◽  
Iv Iron ◽  
The Impact ◽  
Extension Trial

Abstract Abstract 5156 BACKGROUND: Iron deficiency anemia (IDA) is the most common cause of anemia worldwide. The World Health Organization (WHO) estimates that as many as 1.6 billion people worldwide (25% of the world’s population) have IDA, and the National Center for Health Statistics estimates that 3.4 million people in the US have IDA. Various underlying conditions have been linked to IDA, which in industrialized nations primarily include chronic kidney disease (CKD), menstrual and postpartum blood loss, pregnancy, gastrointestinal (GI) blood loss, and cancer. Regardless of underlying cause, iron replacement therapy is essential for increasing iron stores and raising hemoglobin levels in patients with IDA. Typically, one gram of iron is the standard IV iron therapeutic dose for the management of IDA. Ferumoxytol is approved in the US for the treatment of IDA in adult subjects with CKD and is marketed under the trade name Feraheme® (ferumoxytol) Injection. Ferumoxytol is administered as two IV injections of 510 mg (17 mL) 3 to 8 days apart, for a total cumulative dose of 1.02 g. METHODS: To provide a convenient, safe, and effective method for increasing iron in patients with IDA and a history of unsatisfactory oral iron therapy, AMAG is undertaking a global Phase III clinical development program. This program includes a randomized, double-blind, placebo-controlled trial in 800 subjects (ClinicalTrials.gov NCT01114139) followed by a sixth-month, open-label extension trial (ClinicalTrials.gov NCT01114217). The primary objective of the double-blind placebo-controlled study is to evaluate the efficacy and safety of a 1.02 g course of IV ferumoxytol, administered as two doses of 510 mg each, compared with placebo (normal saline). This trial will randomize subjects to ferumoxytol or placebo at a ratio of 3:1. Subjects will have a variety of underlying conditions including ongoing abnormal uterine bleeding (AUB), GI disorders (eg, inflammatory bowel disease, gastric bypass), cancer, postpartum blood loss, and other conditions such as nutritional iron deficiency, heart failure, and rheumatoid arthritis. Following study completion (a 5-week treatment period) all subjects will have an opportunity to enroll into the extension trial (NCT01114217), which will evaluate the safety and efficacy of ferumoxytol for the episodic treatment of IDA over a 6-month period. In both trials, key efficacy endpoints will be based on evaluations of hemoglobin through 5 weeks following treatment with ferumoxytol. Additional assessments will include change in transferrin saturation, and the impact of ferumoxytol treatment on both the use of erythropoiesis stimulating agents and the need for blood transfusions. Both of these trials will also include patient reported outcomes to assess the impact of IV iron therapy on anemia symptoms and health-related quality of life (fatigue, energy). Additionally, detailed information on healthcare utilization will be collected. CONCLUSION: In addition to providing efficacy, safety, and patient reported outcome information on the administration of ferumoxytol for the treatment of IDA in a broad patient population, these trials (NCT01114139 and NCT01114217) will contribute novel data regarding the requirement for repeat therapy with IV iron and the safety and efficacy of long-term repeat use of IV iron in the treatment of IDA. Disclosures: Poma: AMAG Pharmaceuticals, Inc.: Employment. Diana:AMAG Pharmaceuticals, Inc.: Employment. McLaughlin:AMAG Pharmaceuticals, Inc.: Employment. Kausz:AMAG Pharmaceuticals, Inc.: Employment.

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