154 Functioning in de Novo and Rollover Patients with Bipolar I Disorder Receiving Aripiprazole Once-monthly in a 52-Week, Open-label Study

Abstract:Introduction:Long-term maintenance treatment is essential in management of bipolar I disorder (BP-I) to achieve mood stability, prevent recurrence of mood episodes and improve functioning. Aripiprazole once-monthly 400 mg (AOM 400) is a long-acting formulation of aripiprazole for maintenance treatment of BP-I. In a double-blind, placebo-controlled, randomized withdrawal study in adult patients with BP-I after a manic episode (NCT01567527), AOM 400 delayed time to and reduced rate of recurrence of mood episodes and was safe and well tolerated (1). In an open-label, long-term safety study (NCT01710709), AOM 400 was safe and effective as long-term maintenance treatment (2).Objective:To evaluate the effect of long-term AOM 400 maintenance treatment on manic and depressive symptoms in BP-I patients from the open-label, long term safety study.Methods:Manic and depressive symptoms were assessed post-hoc by analysis of change from study entry in the Young-Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and line item scores. The mean changes from baseline at last visit in YMRS and MADRS total scores, and single items were calculated using descriptive statistics, using last observation carried forward for total scores and observed cases for single items.Results:A total of 464 patients entered the maintenance phase: 379 were de novo and 85 were rollover patients who completed the double-blind, placebo-controlled withdrawal study. Overall, 63% (291/464) completed 52 weeks of open-label treatment. Mean YMRS and MADRS total scores were minimally changed from baseline (YMRS: 2.31, endpoint change -0.30; MADRS: 3.23, endpoint change +1.24) across the study in the total population.Conclusion:Patients entering an open-label safety study with stable manic and depressive symptoms maintained stability in both types of symptoms, as shown by minimal mean changes from baseline in YMRS and MADRS scores, suggesting that treatment with AOM 400 is effective in preventing re-emergence of both manic and depressive symptoms.Funding Acknowledgements:The study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.

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Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

Ukrains'kyi Visnyk Psykhonevrolohii ◽

10.36927/2079-0325-v28-is3-2020-5 ◽

2020 ◽

pp. 27-37

Author(s):

Suresh Durgam ◽

Willie Earley ◽

Rui Li ◽

Dayong Li ◽

Kaifeng Lu ◽

...

Keyword(s):

Safety Profile ◽

Relapse Prevention ◽

Controlled Trial ◽

Fixed Dose ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Randomized Controlled ◽

Time To Relapse

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics

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Continuation and long-term maintenance treatment with Hypericum extract WS® 5570 after recovery from an acute episode of moderate depression — A double-blind, randomized, placebo controlled long-term trial

European Neuropsychopharmacology ◽

10.1016/j.euroneuro.2008.06.006 ◽

2008 ◽

Vol 18 (11) ◽

pp. 803-813 ◽

Cited By ~ 31

Author(s):

S. Kasper ◽

H.P. Volz ◽

H.J. Möller ◽

A. Dienel ◽

M. Kieser

Keyword(s):

Maintenance Treatment ◽

Acute Episode ◽

Double Blind ◽

Moderate Depression ◽

Term Trial ◽

Hypericum Extract ◽

Term Maintenance

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Long-term efficacy and safety of agomelatine in non-depressed out-patients with generalized anxiety disorder. A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25 mg/day with the possibility for blinded dose-adjustment to 50 mg/day)

http://isrctn.org/> ◽

10.1186/isrctn38094599 ◽

2012 ◽

Author(s):

Istvan Bitter

Keyword(s):

Anxiety Disorder ◽

Generalized Anxiety Disorder ◽

Dose Adjustment ◽

Generalized Anxiety ◽

Efficacy And Safety ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Parallel Group

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Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽

10.1017/s1092852900023075 ◽

2005 ◽

Vol 10 (6) ◽

pp. 3-5

Author(s):

Richard H. Weisler

Keyword(s):

Extended Release ◽

Rating Scale ◽

Controlled Trial ◽

Controlled Study ◽

Mixed States ◽

Open Label ◽

Young Mania ◽

Double Blind ◽

Double Blind Placebo ◽

Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

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EPA-0666 – Long-term maintenance of efficacy of extended-release guanfacine hydrochloride (GXR) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD): double-blind, placebo-controlled, multicentre, phase 3 randomized withdrawal study

European Psychiatry ◽

10.1016/s0924-9338(14)78034-4 ◽

2014 ◽

Vol 29 ◽

pp. 1 ◽

Cited By ~ 3

Author(s):

J. Newcorn ◽

V. Harpin ◽

M. Huss ◽

M. Johnson ◽

J.A. Ramos-Quiroga ◽

...

Keyword(s):

Attention Deficit Hyperactivity Disorder ◽

Attention Deficit ◽

Extended Release ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

Multicentre Phase ◽

Hyperactivity Disorder ◽

Term Maintenance

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Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽

10.1017/s1092852900024500 ◽

2005 ◽

Vol 10 (S1) ◽

pp. 3-5

Author(s):

Richard H. Weisler

Keyword(s):

Extended Release ◽

Rating Scale ◽

Controlled Trial ◽

Controlled Study ◽

Mixed States ◽

Open Label ◽

Young Mania ◽

Double Blind ◽

Double Blind Placebo ◽

Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

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Aripiprazole once-monthly 400 mg for long-term maintenance treatment of schizophrenia: a 52-week open-label study

npj Schizophrenia ◽

10.1038/npjschz.2015.39 ◽

2015 ◽

Vol 1 (1) ◽

Cited By ~ 6

Author(s):

Timothy Peters-Strickland ◽

Ross A Baker ◽

Robert D McQuade ◽

Na Jin ◽

Anna Eramo ◽

...

Keyword(s):

Maintenance Treatment ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Term Maintenance

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P.3.d.035 Aripiprazole once-monthly for long-term maintenance treatment of schizophrenia: a 52-week open-label study

European Neuropsychopharmacology ◽

10.1016/s0924-977x(14)70868-5 ◽

2014 ◽

Vol 24 ◽

pp. S542

Author(s):

T. Peters-Strickland ◽

R.A. Baker ◽

R. McQuade ◽

N. Jin ◽

A. Eramo ◽

...

Keyword(s):

Maintenance Treatment ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Term Maintenance

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MERIDIAN: A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in patients with amyotrophic lateral sclerosis

10.5327/1516-3180.744 ◽

2021 ◽

Author(s):

Frederico Mennucci de Haidar Jorge ◽

Angela Genge ◽

Ammar Al- Chalabi ◽

Orla Hardiman ◽

Alice Shen ◽

...

Keyword(s):

Amyotrophic Lateral Sclerosis ◽

Rating Scale ◽

Phase 2 ◽

Efficacy And Safety ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Sporadic Als ◽

The Difference ◽

Lateral Sclerosis

Introduction: Inflammation underlies the pathogenesis of numerous neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS). In ALS, the complement system has been implicated in the neuropathology of disease and disease progression. Pegcetacoplan, a subcutaneously administered C3 complement inhibitor, is being investigated in hematology, nephrology, and neurology. The current clinical study (NCT04579666) is investigating whether pegcetacoplan can improve survival and function in people diagnosed with apparent sporadic ALS. Objectives and Methodology: Evaluate the efficacy and safety of pegcetacoplan compared to placebo among people diagnosed with ALS in a global, multicenter, randomized, double-blind, placebo-controlled, phase 2 study. Approximately 228 patients diagnosed with apparent sporadic ALS, ≥18 years of age and with an ALS Functional Rating Scale-Revised (ALSFRS-R) score ≥30, slow vital capacity (SVC) ≥60% of the predicted value at screening, and with symptom onset within 72 weeks before screening, are eligible for enrollment. After screening, patients will be randomized 2:1 to treatment groups receiving either subcutaneous pegcetacoplan (1080 mg) or placebo twice weekly for a duration of 52 weeks. The primary efficacy endpoint is the difference in the Combined Assessment of Function and Survival (CAFS) ranked score at 52 weeks after treatment initiation. Additional, secondary functional efficacy (ALSFRS-R, percent SVC, muscle strength, quality of life, and caregiver burden) and safety endpoints will be analyzed at 52 weeks. After the placebo-controlled period, all patients will have the option to receive pegcetacoplan in an open-label period for an additional 52 weeks. Results: This ongoing study is currently enrolling participants. Conclusions: Results of this study will determine the role of complement and C3 inhibition in patients with ALS.

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