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.
Treatment Resistant Depression (TRD), Late Life Depression (LLD)
Lumateperone for Late-Life Depression
The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S.
- Conditions
- Treatment Resistant Depression (TRD), Late Life Depression (LLD), Depression / Major Depressive Disorder
- Trial name
- IRL Grey-C (NCT07623135)
- Testing
- Lumateperone
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Eric Lenze
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.
Borderline Personality Disorder
Caplyta in Borderline Personality Disorder
The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD).
- Trial name
- NCT05356013
- Testing
- Caplyta
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Chicago
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.