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.
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.
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.
Major Depressive Disorder
An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point…
- Trial name
- NCT05061719
- Testing
- Lumateperone
- Where
- 109 sites in United States, Bulgaria and 9 more
- Volunteers
- 812 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Depression
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B.
- Trial name
- NCT02600494
- Testing
- ITI-007 (Lumateperone)
- Where
- 55 sites in United States
- Volunteers
- 554 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Schizophrenia
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis.
- Trial name
- NCT01499563
- Testing
- ITI-007, Risperidone
- Where
- 8 sites in United States
- Volunteers
- 335 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Schizophrenia
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation…
- Trial name
- NCT02469155
- Testing
- ITI-007, Risperidone
- Where
- 11 sites in United States
- Volunteers
- 696 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Schizophrenia
A Trial to Assess the Antipsychotic Efficacy of ITI-007
The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
- Trial name
- NCT02282761
- Testing
- ITI-007
- Where
- 11 sites in United States
- Volunteers
- 450 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Major Depressive Disorder
Multicenter 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
- NCT05061706
- Testing
- Lumateperone
- Where
- 50 sites in United States, Argentina and 5 more
- Volunteers
- 480 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Major Depressive Disorder
Clinical Trial 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
- NCT04985942
- Testing
- Lumateperone
- Where
- 54 sites in United States, Bulgaria and 4 more
- Volunteers
- 485 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Depression, Major Depressive Disorder
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or…
- Trial name
- NCT04285515
- Testing
- Lumateperone
- Where
- 42 sites in United States, Bulgaria and 3 more
- Volunteers
- 488 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Depression
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar…
- Trial name
- NCT02600507
- Testing
- Lumateperone (ITI-007)
- Where
- 71 sites in United States, Bulgaria and 3 more
- Volunteers
- 529 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Depression
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major…
- Trial name
- NCT03249376
- Testing
- Lumateperone
- Where
- 47 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Agitation in Dementia, Including Alzheimer's Disease
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including…
- Trial name
- NCT02817906
- Testing
- ITI-007
- Where
- 26 sites in United States
- Volunteers
- 177 people
- Sponsor
- Intra-Cellular Therapies, Inc.