Clinical trials: sponsored by 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.
Healthy Volunteers
A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects
This is an open-label, single-dose study of up to 4 dose levels of ITI-333 in healthy male and female subjects. Each cohort will enroll 6 subjects.
- Trial name
- NCT05470101
- Testing
- ITI-333
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- 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.
Healthy Volunteers
A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects
ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of [14C]-ITI-1284…
- Trial name
- NCT06786286
- Testing
- [14C]-ITI-1284
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- 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.
Healthy Volunteers
Single 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 8 sequential cohorts of healthy subjects.
- Trial name
- NCT04934124
- Testing
- ITI-333
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Intra-Cellular Therapies, Inc.
Schizophrenia
Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
This is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia.
- Trial name
- NCT04709224
- Testing
- Lumateperone Long-Acting Injectable
- Where
- 2 sites in United States
- Volunteers
- 37 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.
Heart Failure, Systolic
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.
- Trial name
- NCT03387215
- Testing
- ITI-214
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Healthy Volunteers
Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to…
- Trial name
- NCT03489772
- Testing
- ITI-214
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Intra-Cellular Therapies, Inc.
Parkinson Disease
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics…
- Trial name
- NCT03257046
- Testing
- ITI-214
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Alzheimer's Disease
Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia
A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia
- Trial name
- NCT02078310
- Testing
- ITI-007
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Intra-Cellular Therapies, Inc.