Intra-Cellular Therapies, Inc. clinical trials

Acquired by Johnson & Johnson, Apr 2, 2025 · source ↗

The registry lists 41 studies whose lead sponsor is Intra-Cellular Therapies, Inc.. 12 are recruiting or about to start. Per ClinicalTrials.gov, last updated Oct 5, 2026.

Studies

Recruiting first, then most recently updated. Showing 41 of 41. All Johnson & Johnson studies →

• 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 TreatmentNot yet recruitingNCT07856420Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted after Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's DementiaRecruitingNCT06651567Phase 2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's DiseaseRecruitingNCT06540833Phase 2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)RecruitingNCT07807865Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted after Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric PatientsRecruitingNCT06706674Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive DisorderRecruitingNCT05850689Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum DisorderRecruitingNCT06229210Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric PatientsRecruitingNCT06372964Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety DisorderRecruitingNCT06701903Phase 2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety DisorderRecruitingNCT06480383Phase 2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric PatientsRecruitingNCT06690398Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• A Study of Lumateperone Versus Placebo in Participants With Major Depressive DisorderNot yet recruitingNCT07747389Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted after Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Lumateperone for the Prevention of Relapse in Patients With SchizophreniaCompletedNCT04959032Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy SubjectsCompletedNCT06299410Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective DisorderCompletedNCT06627413Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Study of Lumateperone in the Acute Treatment of Patients With Bipolar ManiaCompletedNCT06462586Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Study of Lumateperone in the Treatment of Patients With Bipolar ManiaCompletedNCT06462612Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's DiseaseCompletedNCT05766813Phase 2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum DisorderCompletedNCT06557902Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy VolunteersCompletedNCT05732194Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective DisorderCompletedNCT04779177Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar DepressionCompletedNCT02600494Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive DisorderCompletedNCT05061719Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Study of a Novel Antipsychotic ITI-007 in SchizophreniaCompletedNCT01499563Phase 2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of TreatmentCompletedNCT02469155Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• A Trial to Assess the Antipsychotic Efficacy of ITI-007CompletedNCT02282761Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• A PET Study Following a Single Oral Dose of ITI-333 in Healthy SubjectsCompletedNCT05470101Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive DisorderCompletedNCT05061706Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive DisorderCompletedNCT04985942Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male SubjectsCompletedNCT06786286Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive DisorderCompletedNCT04285515Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar DepressionCompletedNCT02600507Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy VolunteersCompletedNCT04934124Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With SchizophreniaCompletedNCT04709224Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted GloballyCompletedNCT03249376Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's DiseaseTerminatedNCT02817906Phase 3

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart FailureCompletedNCT03387215Phase 1/2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Study of ITI-214 in Healthy Volunteers to Determine CNS EngagementCompletedNCT03489772Phase 1

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's DiseaseCompletedNCT03257046Phase 1/2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With DementiaCompletedNCT02078310Phase 1/2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson

• Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable SchizophreniaCompletedNCT02288845Phase 2

  Sponsor listed in the registry: Intra-Cellular Therapies, Inc. · First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson