Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Bipolar I Disorder
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder
The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following…
- Trial name
- NCT04030143
- Testing
- Aripiprazole
- Where
- 19 sites in United States
- Volunteers
- 266 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Alzheimer's Disease
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type…
- Trial name
- NCT03594123
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder
Major depressive disorder (MDD) is a serious medical illness associated with significant suicidal risk and marked disability. Despite the availability of numerous treatments, achievement of consistent and favorable long-term…
- Trial name
- NCT03538691
- Testing
- Brexpiprazole, Antidepressant therapy
- Where
- United States
- Volunteers
- 1,149 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation Associated With Alzheimer's Dementia, Alzheimer Dementia
A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
- Trial name
- NCT03548584
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 345 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention-deficit Hyperactivity Disorder
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.
- Trial name
- NCT04786730
- Testing
- Centanafadine
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole…
- Trial name
- NCT00261443
- Testing
- Lithium or Valproate with Aripiprazole
- Where
- 83 sites in United States, Brazil and 7 more
- Volunteers
- 1,270 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National…
- Trial name
- NCT02442765
- Testing
- AVP-786
- Where
- 126 sites in United States, Estonia and 4 more
- Volunteers
- 387 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Hyperactivity Disorder
Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved stimulant medication to explore a possible impact…
- Trial name
- STEP-A (NCT01074294)
- Testing
- OPDC-34712, Stimulant Therapy
- Where
- 35 sites in United States
- Volunteers
- 740 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder (MDD)
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.
- Trial name
- NCT05504486
- Testing
- Brexpiprazole
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Hyperactivity Disorder
Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)
With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal…
- Trial name
- NCT04081363
- Testing
- Centanafadine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)
The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- NCT02964273
- Testing
- Tolvaptan
- Where
- 20 sites in Belgium, Germany and 2 more
- Volunteers
- 91 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Participants With Dementia of the Alzheimer's Type
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National…
- Trial name
- NCT02442778
- Testing
- AVP-786-18, AVP-786-28, AVP-786-42.63
- Where
- 83 sites in United States, Canada
- Volunteers
- 522 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Epilepsy
A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870
Despite availability of several antiepileptic drugs (AEDs), in one-third of patients, epilepsy remains uncontrolled with AEDs. There is a need to develop new approaches to improve the existing medications to relieve patients'…
- Trial name
- NCT04241965
- Testing
- OPC-214870
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Hyperactivity Disorder
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine in Pediatric Subjects With Attention-deficit/Hyperactivity Disorder
This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in pediatric subjects with ADHD.
- Trial name
- NCT04398225
- Testing
- Centanafadine
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Intermittent Explosive Disorder
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).
- Trial name
- NCT03420222
- Testing
- AVP-786
- Where
- 9 sites in United States
- Volunteers
- 10 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
This study evaluates the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD).
- Trial name
- NCT03605680
- Testing
- Centanafadine SR
- Where
- United States
- Volunteers
- 604 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Adult Attention-deficit Hyperactivity Disorder (ADHD)
A Phase 1 Study to Investigate the Safety, Tolerance, Food Effect, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Extended Release Formulations of Centanafadine (CTN) in Young Healthy Subjects
The purpose of this study is to investigate the safety, tolerance, food effect, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of extended release (XR) formulations of Centanafadine (CTN) in Young…
- Trial name
- NCT02827513
- Testing
- CTN SR1, CTN XR1, CTN XR2
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Drug-drug Interaction
A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine.
- Trial name
- NCT02174822
- Testing
- AVP-786, Paroxetine, Duloxetine
- Where
- Australia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder (MDD)
To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This is a multicenter, 52-week, open-label study designed to assess the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with major depressive disorder (MDD).
- Trial name
- NCT01123707
- Testing
- Aripiprazole, Escitalopram
- Volunteers
- 173 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an…
- Trial name
- NCT01111565
- Testing
- Escitalopram, Aripiprazole
- Where
- 53 sites in United States, Canada and 9 more
- Volunteers
- 137 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.