Clinical trials: sponsored by Intra-Cellular Therapies, Inc.
Schizophrenia
Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of…
- Trial name
- NCT04959032
- Testing
- Lumateperone 42 mg
- Where
- 43 sites in United States, Bulgaria and 2 more
- Volunteers
- 592 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Generalized Anxiety Disorder
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder…
- Trial name
- NCT07856420
- Testing
- JNJ-99245354
- Volunteers
- 705 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Generalized Anxiety Disorder
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded…
- Trial name
- NCT07807865
- Testing
- ITI-1284
- Where
- 3 sites in United States
- Volunteers
- 900 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Psychotic Disorders, Alzheimer Disease
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in…
- Trial name
- NCT06540833
- Testing
- ITI-1284
- Where
- 69 sites in United States, Bulgaria and 8 more
- Volunteers
- 370 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Agitation Associated With Alzheimer's Dementia
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.
- Trial name
- NCT06651567
- Testing
- ITI-1284
- Where
- 70 sites in United States, Bulgaria and 6 more
- Volunteers
- 320 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06690398
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 35 sites in United States
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Major Depressive Disorder
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders…
- Trial name
- NCT05850689
- Testing
- Lumateperone
- Where
- 69 sites in United States, Bulgaria and 5 more
- Volunteers
- 470 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Depression
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as…
- Trial name
- NCT06372964
- Testing
- Lumateperone
- Where
- 68 sites in United States, Colombia and 2 more
- Volunteers
- 384 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Healthy Volunteers
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.
- Trial name
- NCT06299410
- Testing
- ITI-1284 10 mg, ITI-1284 20 mg
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Intra-Cellular Therapies, Inc.
Generalized Anxiety Disorder
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental…
- Trial name
- NCT06701903
- Testing
- ITI-1284 10 mg, ITI-1284 20 mg
- Where
- 51 sites in United States, Bulgaria and 3 more
- Volunteers
- 570 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Generalized Anxiety Disorder
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic…
- Trial name
- NCT06480383
- Testing
- ITI-1284 10 mg, ITI-1284 20 mg
- Where
- 56 sites in United States, Bulgaria and 3 more
- Volunteers
- 705 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06706674
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 40 sites in United States
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Schizophrenia, Bipolar Disorder
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
- Conditions
- Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
- Trial name
- NCT06229210
- Testing
- Lumateperone
- Where
- 65 sites in United States, Colombia and 1 more
- Volunteers
- 300 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Depressive Disorder, Major
A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder
The purpose of the study is to assess how well each dose of lumateperone (Dose 1 and 2) works when given alone as compared to placebo in participants with major depressive disorder (MDD; a medical condition characterized by a…
- Trial name
- CANDLE (NCT07747389)
- Testing
- Lumateperone
- Volunteers
- 585 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Schizophrenia or Schizoaffective
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia…
- Trial name
- NCT06627413
- Testing
- Lumateperone Capsule, Lumateperone LAI
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Parkinson Disease
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank…
- Trial name
- NCT05766813
- Testing
- Lenrispodun
- Where
- 35 sites in United States
- Volunteers
- 79 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Disorder, Manic
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with…
- Trial name
- NCT06462612
- Testing
- Lumateperone
- Where
- 35 sites in United States, Bulgaria and 2 more
- Volunteers
- 351 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Autism Spectrum Disorder
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.
- Trial name
- NCT06557902
- Testing
- Lumateperone 10.5 mg capsule, Lumateperone 21 mg capsule, Lumateperone 5 mg ODT
- Where
- 7 sites in United States
- Volunteers
- 33 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Disorder, Manic
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with…
- Trial name
- NCT06462586
- Testing
- Lumateperone
- Where
- 42 sites in United States, Bulgaria and 3 more
- Volunteers
- 354 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Healthy Volunteers
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects.
- Trial name
- NCT05732194
- Testing
- ITI-333
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Intra-Cellular Therapies, Inc.