Willie Earley
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View article: Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder
Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder Open
Trial Registration: ClinicalTrials.gov identifier: NCT04985942.
View article: A Randomized, Double-blind Study of the Efficacy and Tolerability of Extended Release Quetiapine Fumarate (Quetiapine XR) Monotherapy in Patients with Major Depressive Disorder
A Randomized, Double-blind Study of the Efficacy and Tolerability of Extended Release Quetiapine Fumarate (Quetiapine XR) Monotherapy in Patients with Major Depressive Disorder Open
Objectives Evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with major depressive disorder (MDD). Methods 10-week (8-week active-treatment/2-week post-treatme…
View article: Cariprazine Augmentation to Antidepressant Therapy in Major Depressive Disorder: Results of a Randomized, Double-Blind, Placebo-Controlled Trial
Cariprazine Augmentation to Antidepressant Therapy in Major Depressive Disorder: Results of a Randomized, Double-Blind, Placebo-Controlled Trial Open
Cariprazine is an atypical antipsychotic currently under investigation as an adjunctive to antidepressant treatment (ADT) for patients with major depressive disorder (MDD). Here results of an 18- to 19-week randomized double-blind placebo-…
View article: Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features
Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features Open
Background This randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov identifer NCT04285515) evaluated efficacy and safety of lumateperone to treat major depressive episodes (MDEs) associated with major depressive disorder…
View article: LUMATEPERONE IN THE TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE DISORDER AND BIPOLAR DISORDER WITH ANXIOUS DISTRESS AND MIXED FEATURES
LUMATEPERONE IN THE TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE DISORDER AND BIPOLAR DISORDER WITH ANXIOUS DISTRESS AND MIXED FEATURES Open
Background Anxious distress and mixed features are DSM-5 episode specifiers for major depressive episodes (MDE) associated with major depressive disorder (MDD) and bipolar disorder. Patients with depressive episodes with the specifiers hav…
View article: LUMATEPERONE TREATMENT FOR MAJOR DEPRESSIVE EPISODES WITH MIXED FEATURES IN MAJOR DEPRESSIVE DISORDER AND BIPOLAR I OR BIPOLAR II DISORDER
LUMATEPERONE TREATMENT FOR MAJOR DEPRESSIVE EPISODES WITH MIXED FEATURES IN MAJOR DEPRESSIVE DISORDER AND BIPOLAR I OR BIPOLAR II DISORDER Open
Background The DSM-5 and DSM-5-TR define mixed features in major depressive disorder (MDD) or bipolar depression (BPD) as having subsyndromal manic or hypomanic symptoms nearly every day during the majority of days of a major depressive ep…
View article: Efficacy of cariprazine in patients with bipolar depression and higher or lower levels of baseline anxiety: a pooled post hoc analysis
Efficacy of cariprazine in patients with bipolar depression and higher or lower levels of baseline anxiety: a pooled post hoc analysis Open
Post hoc analyses evaluated cariprazine, a dopamine D 3 -preferring D 3 /D 2 receptor partial agonist, in patients with bipolar I depression and high baseline anxiety. Data were pooled from two phase 3, randomized, double-blind, placebo-co…
View article: Safety and Tolerability of Cariprazine for the Adjunctive Treatment of Major Depressive Disorder: A Pooled Analysis of Phase 2B and 3 Clinical Trials
Safety and Tolerability of Cariprazine for the Adjunctive Treatment of Major Depressive Disorder: A Pooled Analysis of Phase 2B and 3 Clinical Trials Open
Background Cariprazine has been shown to be efficacious in placebo-controlled clinical trials. In this pooled analysis, the safety of cariprazine in patients with major depressive disorder (MDD) with inadequate response to antidepressants …
View article: Pharmacokinetics, Safety, and Tolerability of Cariprazine in Pediatric Patients with Bipolar I Disorder or Schizophrenia
Pharmacokinetics, Safety, and Tolerability of Cariprazine in Pediatric Patients with Bipolar I Disorder or Schizophrenia Open
Objective: Cariprazine is a dopamine D3-preferring D3/D2 and serotonin 5-HT1A receptor partial agonist approved to treat adults with schizophrenia and manic/mixed or depressive episodes associated with bipolar I disorder. This sequential-c…
View article: Minimal Effects of Cariprazine on Prolactin Levels in Bipolar Disorder and Schizophrenia
Minimal Effects of Cariprazine on Prolactin Levels in Bipolar Disorder and Schizophrenia Open
Treatment with cariprazine for schizophrenia or bipolar I disorder was associated with minimal effects on prolactin levels.
View article: The efficacy of cariprazine on cognition: a post hoc analysis from phase II/III clinical trials in bipolar mania, bipolar depression, and schizophrenia
The efficacy of cariprazine on cognition: a post hoc analysis from phase II/III clinical trials in bipolar mania, bipolar depression, and schizophrenia Open
Objective To investigate the effect of cariprazine on cognitive symptom change across bipolar I disorder and schizophrenia. Methods Post hoc analyses of 3- to 8-week pivotal studies in bipolar I depression and mania were conducted; one sch…
View article: Disentangling the symptoms of schizophrenia: Network analysis in acute phase patients and in patients with predominant negative symptoms
Disentangling the symptoms of schizophrenia: Network analysis in acute phase patients and in patients with predominant negative symptoms Open
Background The Positive and Negative Syndrome Scale (PANSS) is widely used in schizophrenia and has been divided into distinct factors (5-factor models) and subfactors. Network analyses are newer in psychiatry and can help to better unders…
View article: Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies [Corrigendum]
Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies [Corrigendum] Open
[This corrects the article DOI: 10.2147/NDT.S301225.].
View article: Tolerability of cariprazine in the early stage of schizophrenia: A pooled, post-hoc analysis of 4 phase ii/iii double-blind placebo-controlled trials
Tolerability of cariprazine in the early stage of schizophrenia: A pooled, post-hoc analysis of 4 phase ii/iii double-blind placebo-controlled trials Open
Introduction In the early stage of schizophrenia (first 5 years), the most important clinical target besides symptom control is relapse prevention as each relapse significantly decreases the possibility of preferable long-term outcomes. Ea…
View article: Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies
Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies Open
Studies registered with ClinicalTrials.gov (NCT00404573, NCT01104779, NCT00694707, NCT01104766, NCT01104792, NCT00839852, and NCT01412060) and EudraCT (2012-005485-36).
View article: Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression
Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression Open
ClinicalTrials.gov Identifiers: NCT01396447, NCT02670538, NCT02670551.
View article: Efficacy of cariprazine in bipolar I depression across patient characteristics: a post hoc analysis of pooled randomized, placebo-controlled studies
Efficacy of cariprazine in bipolar I depression across patient characteristics: a post hoc analysis of pooled randomized, placebo-controlled studies Open
Patients who experience bipolar depression have diverse demographic and clinical characteristics that have the potential to impact treatment. The efficacy of cariprazine in bipolar I depression was evaluated in patient subgroups defined by…
View article: Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications
Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications Open
ClinicalTrials.gov identifiers: NCT01396447, NCT02670538, NCT02670551.
View article: 145 Incidence and Characteristics of Akathisia and Restlessness During Cariprazine Treatment for Bipolar I Disorder
145 Incidence and Characteristics of Akathisia and Restlessness During Cariprazine Treatment for Bipolar I Disorder Open
Study Objective: Akathisia and restlessness are common adverse events associated with atypical antipsychotic use; in severe cases, symptoms may lead to treatment discontinuation. Cariprazine, a dopamine D3/D2 receptor partial agonist with …
View article: 156 The Broad Efficacy of Cariprazine Across Symptoms in Patients with Bipolar I Disorder: Post Hoc Analysis of Randomized, Placebo-Controlled Trials
156 The Broad Efficacy of Cariprazine Across Symptoms in Patients with Bipolar I Disorder: Post Hoc Analysis of Randomized, Placebo-Controlled Trials Open
Study Objective: Patients with bipolar disorder experience a wide range of depressive and manic symptoms. Only 2 drugs are FDA-approved to treat episodes of both mania and depression in patients with bipolar disorder, highlighting the need…
View article: Evaluation of cariprazine in the treatment of bipolar I and II depression: a randomized, double-blind, placebo-controlled, phase 2 trial
Evaluation of cariprazine in the treatment of bipolar I and II depression: a randomized, double-blind, placebo-controlled, phase 2 trial Open
This double-blind placebo-controlled, fixed/flexible-dose phase 2 trial assessed the efficacy, safety, and tolerability of cariprazine vs. placebo for depressive episodes associated with bipolar I or II disorder. Primary endpoint was chang…
View article: A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression
A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression Open
clinicaltrials.gov NCT00852202, NCT01396447, NCT02670538, NCT02670551.
View article: Relationship Between Plasma Concentrations and Clinical Effects of Cariprazine in Patients With Schizophrenia or Bipolar Mania
Relationship Between Plasma Concentrations and Clinical Effects of Cariprazine in Patients With Schizophrenia or Bipolar Mania Open
Population pharmacokinetic/pharmacodynamic modeling (via NONMEM) was used to describe longitudinal exposure‐response relationships for total cariprazine (sum of cariprazine and its major active metabolites) in 2,558 patients with schizophr…
View article: Efficacy and safety of cariprazine in bipolar I depression: A double‐blind, placebo‐controlled phase 3 study
Efficacy and safety of cariprazine in bipolar I depression: A double‐blind, placebo‐controlled phase 3 study Open
Objective To assess the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults ( NCT02670538 ). Methods In this phase 3 double‐blind placebo‐controlled study, adult patient…
View article: Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies
Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies Open
Objective. Mixed presentations, defined by simultaneous occurrence of depressive and manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak evidence of efficacy and may increase risk of mood destabilizat…
View article: <p>Relationship between the timing of relapse and plasma drug levels following discontinuation of cariprazine treatment in patients with schizophrenia: indirect comparison with other second-generation antipsychotics after treatment discontinuation</p>
Relationship between the timing of relapse and plasma drug levels following discontinuation of cariprazine treatment in patients with schizophrenia: indirect comparison with other second-generation antipsychotics after treatment discontinuation Open
Discontinuation of cariprazine treatment appeared to be associated with a delayed incidence of relapse compared with other AAPs, which may be due to the longer half-life of cariprazine and its active metabolites.