Clinical trials: sponsored by 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.
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
- 39 sites in United States, Serbia
- Volunteers
- 160 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
- 41 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.
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
- 59 sites in United States, Bulgaria and 4 more
- Volunteers
- 705 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.
Schizophrenia, Pediatric
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.
- Trial name
- NCT04779177
- Testing
- Lumateperone 42 mg, Lumateperone 28 mg
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- Intra-Cellular Therapies, Inc.