Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication
This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
- Trial name
- NCT05628103
- Testing
- SEP-363856
- Where
- 25 sites in United States
- Volunteers
- 101 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Disorder With Hyperactivity
A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels
The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single…
- Trial name
- NCT07253441
- Testing
- CTN XR (TBM), CTN SR, CTN XR (Clin)
- Where
- 2 sites in United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
- Trial name
- NCT05741528
- Testing
- SEP-363856
- Where
- 16 sites in United States
- Volunteers
- 75 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Neurobehavioral Disinhibition
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury…
- Trial name
- NCT03095066
- Testing
- AVP-786-28, AVP-786-42.63
- Where
- 54 sites in United States
- Volunteers
- 168 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
- Trial name
- NCT02446132
- Testing
- AVP-786
- Where
- 227 sites in United States, Bulgaria and 8 more
- Volunteers
- 1,197 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Generalized Anxiety Disorder
A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder
A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old.
- Trial name
- NCT05729373
- Testing
- SEP-363856
- Where
- 83 sites in United States, Bulgaria and 6 more
- Volunteers
- 434 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Binge-Eating Disorder
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
The primary objective of this study is to assess the efficacy of 2 doses of centanafadine sustained-release (SR) (200 milligrams [mg] and 400 mg total daily dose [TDD]) compared with placebo in adults with moderate to severe…
- Trial name
- NCT05113953
- Testing
- Centanafadine
- Where
- 25 sites in United States
- Volunteers
- 147 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Irritability Associated With Autism Spectrum Disorder (ASD)
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
- Trial name
- NCT04174365
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Post Traumatic Stress Disorder
Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult participants with Post-Traumatic Stress Disorder.
- Trial name
- NCT04124614
- Testing
- Brexpiprazole, Sertraline
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Smoking Cessation
Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment
This study will explore the efficacy and tolerability of centanafadine at a dose of 400 mg per day of centanafadine in promoting smoking abstinence in adult smokers seeking to quit.
- Trial name
- NCT05066724
- Testing
- Centanafadine
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with…
- Trial name
- NCT04464564
- Testing
- AVP-786
- Where
- 106 sites in United States, Belgium and 11 more
- Volunteers
- 241 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with…
- Trial name
- NCT04408755
- Testing
- AVP-786
- Where
- 95 sites in United States, Bulgaria and 9 more
- Volunteers
- 184 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Post Traumatic Stress Disorder
Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress…
- Trial name
- NCT04174170
- Testing
- Brexpiprazole, Sertraline
- Where
- United States
- Volunteers
- 591 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging
A clinical study to investigate the effect of an investigational drug as an added medication to an antipsychotic, in adults with schizophrenia, as measured positron emission tomography (PET) imaging .
- Trial name
- NCT04038957
- Testing
- SEP-363856
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied.
- Trial name
- NCT04109950
- Testing
- SEP-363856
- Where
- 78 sites in United States, Bulgaria and 6 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
- Trial name
- NCT03393520
- Testing
- AVP-786
- Where
- 211 sites in United States, Australia and 9 more
- Volunteers
- 601 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
This study compares the effectiveness of 2 digital therapeutics in adult participants diagnosed with major depressive disorder (MDD) who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.
- Trial name
- MIRAI (NCT04770285)
- Testing
- CT-152 - Digital Therapeutic
- Where
- United States
- Volunteers
- 386 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Borderline Personality Disorder
Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)
This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.
- Trial name
- NCT04186403
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder
This study evaluated the long-term safety and tolerability of centanafadine sustained-release (SR) tablets, administered twice daily (BID) in the treatment of adults with attention deficit hyperactivity disorder (ADHD).
- Trial name
- NCT03605849
- Testing
- Centanafadine SR
- Where
- United States
- Volunteers
- 662 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention-Deficit/Hyperactivity Disorder
A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder
This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder…
- Trial name
- NCT05257265
- Testing
- Centanafadine Hydrochloride
- Where
- United States
- Volunteers
- 459 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.