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36 Schizophrenia Trials near Irvine, CA
Power is an online platform that helps thousands of Schizophrenia patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerValbenazine for Schizophrenia
Santa Ana, California
The primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.
Stay on current meds
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Depression, Substance Use, Others
Must Be Taking:Antipsychotics
442 Participants Needed
LB-102 for Schizophrenia
Santa Ana, California
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Not Listed
350 Participants Needed
KarXT for Schizophrenia
Costa Mesa, California
This trial tests KarXT, a combination of two drugs, for people who haven't improved with their current treatment. KarXT aims to balance brain functions and reduce side effects. The study will look at improvements in health and daily life. KarXT has shown positive results in earlier tests.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Treatment-resistant Schizophrenia, Severe Medical Conditions, Others
Must Be Taking:Atypical Antipsychotics
360 Participants Needed
Long-term Safety of Iclepertin for Schizophrenia
Costa Mesa, California
This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term.
Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.
Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.
The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 51
Key Eligibility Criteria
Disqualifiers:Not Listed
1361 Participants Needed
TV-44749 for Schizophrenia
Santa Ana, California
This trial is testing a new medication called TV-44749 to see if it helps adults with schizophrenia, especially those with worsening symptoms. The medication likely works by balancing brain chemicals to reduce symptoms. The study will last over a year, with different phases to test both its effectiveness and safety.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Not Listed
675 Participants Needed
Dexmedetomidine for Agitation in Schizophrenia and Bipolar Disorder
Santa Ana, California
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
450 Participants Needed
KarXT for Schizophrenia
Orange, California
This trial tests the safety and tolerability of KarXT, a combination of two drugs, in schizophrenia patients who haven't responded well to their current treatments. KarXT aims to improve symptoms and manage side effects better than existing medications. KarXT (xanomeline plus trospium) is an emerging treatment for schizophrenia, showing promise in managing total, positive, and negative symptoms.
Stay on current meds
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Suicidal Behavior, Pregnant, Urinary Retention, Others
Must Be Taking:Antipsychotics
280 Participants Needed
SEP-363856 for Schizophrenia
Garden Grove, California
This is a Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Alcohol Use, Substance Use, Bipolar, Others
Must Be Taking:Antipsychotics
522 Participants Needed
Digital Therapeutics for Schizophrenia
Orange, California
This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other DSM-5 Diagnoses, Others
Must Be Taking:Antipsychotics
432 Participants Needed
OLZ/SAM vs. Olanzapine for Schizophrenia or Bipolar Disorder
Anaheim, California
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Major Depressive Episode, Seizure Disorder, Diabetes, Others
Must Be Taking:Antipsychotics
220 Participants Needed
Brexpiprazole for Adolescent Schizophrenia
Anaheim, California
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:13 - 17
Key Eligibility Criteria
Disqualifiers:Delirium, Dementia, Amnesia, Others
Must Be Taking:Antipsychotics
295 Participants Needed
Lumateperone for Schizophrenia and Bipolar Disorder
Anaheim, California
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia or bipolar disorder.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Suicidal Risk, Catatonia, Psychotic Features, Others
Must Be Taking:Psychostimulants
500 Participants Needed
OLZ/SAM for Schizophrenia
Anaheim, California
This trial evaluates the safety and tolerability of OLZ/SAM in children and adolescents with schizophrenia or Bipolar I disorder. OLZ/SAM combines olanzapine to manage symptoms and samidorphan to reduce weight gain. Olanzapine is a well-established antipsychotic effective for schizophrenia and bipolar I disorder, but its use is limited by significant weight gain; samidorphan is added to mitigate this side effect.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Suicide Risk, Pregnancy, Others
Must Be Taking:OLZ/SAM
236 Participants Needed
Xanomeline + Trospium for Schizophrenia
Garden Grove, California
The study design is a de-escalation of current atypical AP treatment to X/T at a maintenance dose of X/T established either at 100 mg xanomeline/20 mg trospium chloride BID (total daily dose 200 mg xanomeline/40 mg trospium chloride) or 125 mg xanomeline/30 mg trospium chloride BID (total daily dose 250 mg xanomeline/60 mg trospium chloride) based on participants' clinical response and/or tolerability. While the package insert for X/T provides guidance for clinicians on dosing, this study is designed to assess how transitioning will occur in the "real world" situation.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Cardiovascular Disease, Hepatic Impairment, Others
Must Be Taking:Atypical Antipsychotics
100 Participants Needed
SPG302 for Schizophrenia
Garden Grove, California
This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Malignancy, CNS Event, Others
Must Be Taking:Antipsychotics
32 Participants Needed
ALTO-101 for Schizophrenia
Garden Grove, California
This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers and measures of cognition.
Additional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:21 - 55
Key Eligibility Criteria
Disqualifiers:Unstable Condition, Bipolar, Dementia, Others
Must Be Taking:Antipsychotics
82 Participants Needed
Emraclidine for Schizophrenia
Orange, California
This trial aims to evaluate the safety and tolerability of a medication called emraclidine, taken by mouth, in adults with schizophrenia.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Cardiovascular, Diabetes, Others
Must Be Taking:Antipsychotics
850 Participants Needed
BXCL501 for Pediatric Schizophrenia and Bipolar Agitation
Anaheim, California
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Acute Intoxication, Suicide Risk, Others
Must Not Be Taking:Benzodiazepines, Hypnotics, Antipsychotics
140 Participants Needed
SEP-363856 for Schizophrenia
Anaheim, California
This trial is testing a new schizophrenia medication called SEP-363856 in people who have already started using it. The goal is to see if it is safe and effective over several months. The medication works by affecting brain chemicals to help reduce symptoms of schizophrenia.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
67 Participants Needed
RL-007 for Cognitive Impairment in Schizophrenia
Orange, California
This trial is testing a new drug, RL-007, to see if it can help people with schizophrenia think and remember better. The study will compare different doses of the drug and check for any side effects. Participants will take the drug for several weeks and complete memory and thinking tests before and after the treatment.
Trial Details
Trial Status:Recruiting
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Not Listed
234 Participants Needed
Why Other Patients Applied
"I've tried lots of drugs and I still have symptoms. I'm not sure of my reality because the things I see and hear are still active. Maybe this will help one way or the other. I would be glad to help others in the future by testing a medication as well."
CY
Schizophrenia PatientAge: 62
"I really would love to be normal. A functioning part of society. It is very hard to hold a job with this condition. I need to be steady. I do NOT like my current meds or ones I've tried before, so new therapies are of interest to me. "
EC
Bipolar Disorder PatientAge: 42
"I’ve been diagnosed with Schizoaffective Disorder for over 5 years now and not found much relief in medication. One I’ve tried helped a bit but the side affects were overwhelming. Hoping I can gain some relief from this disorder and help advance research as well!"
MX
Schizophrenia PatientAge: 44
"I'm willing to try anything to help improve and manage my schizophrenia in any way. I do my best each day to keep the hallucinations at bay. I no longer hear voices but I don't want them to come back either. Most medicine I've tried hasn't help very much."
ZC
Schizophrenia PatientAge: 39
"I would like to get a medication that has fewer side effects than the ones I've used. Many antipsychotics just make me numb or flat and I can't really think. Also I like the idea of helping in research to find better medications for schizephrenia."
VT
Schizophrenia PatientAge: 60
Cariprazine for Pediatric Schizophrenia
Orange, California
This trial is testing the safety and effectiveness of cariprazine in children and teens with schizophrenia, bipolar I disorder, or autism. The goal is to see if the medication is safe and beneficial for use in these young patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Major Depressive, Schizoaffective, Intellectual Disability, Others
310 Participants Needed
TV-44749 vs Oral Olanzapine for Schizophrenia
Los Alamitos, California
The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.
A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia.
Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.
The total duration of participation in the trial for each participant is planned to be approximately 21 weeks.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Diabetes, Hepatic Disorder, Arrhythmia, Others
Must Be Taking:Olanzapine
116 Participants Needed
KarXT for Schizophrenia
Los Alamitos, California
The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
173 Participants Needed
Brilaroxazine for Schizophrenia
Garden Grove, California
This trial tests Brilaroxazine, a daily pill, in patients with severe mental health issues. It aims to improve mood and reduce symptoms. The study lasts for more than a year.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
690 Participants Needed
Lumateperone for Schizophrenia
Los Alamitos, California
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 or schizoaffective disorder.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Other Psychiatric Conditions, Suicidal Ideation, Others
72 Participants Needed
ABBV-932 for Generalized Anxiety Disorder
Los Alamitos, California
This trial tests a new medication called ABBV-932 to see how it works in the body and if it is safe for healthy adults and those with anxiety or bipolar disorder.
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
72 Participants Needed
NBI-1117568 for Schizophrenia
Pico Rivera, California
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Unstable Condition, Others
Must Not Be Taking:Antipsychotics
284 Participants Needed
NaBen Add-On Therapy for Schizophrenia
Pasadena, California
This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia.
Part 1 Objectives: There are two primary objectives for Part 1 of this study:
1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study.
2. Sample size re-assessment to evaluate the final sample size needed to proceed with Part 2 of the study The secondary objective of the Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), in combination with clozapine.
Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with clozapine.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Bipolar, Major Depression, Substance Abuse, Others
Must Be Taking:Clozapine
287 Participants Needed
MDMA for Schizophrenia
Los Angeles, California
Impaired social motivation, or "asociality," is a negative symptom of schizophrenia (SCZ) and a cause of significant functional impairment in the illness. Whereas many symptoms of schizophrenia can be treated with antipsychotic medications, deficits in social motivation persist, leading to significant social disability in patients. There is currently no effective treatment for this symptom of the illness. One promising and unexplored avenue to enhance social motivation in schizophrenia is ± 3,4-methylenedioxymethamphetamine (MDMA). MDMA is a psychostimulant that shares some pharmacological properties with amphetamines, but in addition, has pronounced pro-social effects, increasing the motivation to engage socially. In healthy volunteers, it produces feelings of empathy and closeness with others and increases attention to positive social cues, perhaps partly through its effects on the social bonding hormone, oxytocin. MDMA has shown promise in other psychiatric conditions such as PTSD. Thus, MDMA could offer a unique therapeutic benefit in patients with SCZ who suffer from impaired social motivation. The investigators plan to take the first step in testing MDMA as a treatment for these social deficits by testing the tolerability of the drug in patients with SCZ. This will be an open-label, ascending-dose, within-subject trial in which participants will receive 40mg, 80mg, or 120mg of MDMA. The doses will be administered in ascending order, but doses will be stopped if subjects experience moderate or greater psychotic symptoms at 24 hours. This trial will assess the tolerability of the drug in this population and guide in the selection of a maximum well-tolerated dose for future studies. The primary tolerability measure will be clinician-rated psychotic symptoms (disorganized speech, delusions, hallucinations) collected at 24 hours after MDMA administration. The results of this project will lay the foundation for further investigations of MDMA and other psychoactive compounds as a treatment for debilitating and difficult-to-treat social deficits in schizophrenia. Future studies will examine interactions between the effects of psychoactive compounds and nonpharmacologic psychosocial interventions targeting social symptoms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Neurological Disease, Cardiovascular Condition, Others
Must Be Taking:Antipsychotics
20 Participants Needed
Low-Dose Buprenorphine for Schizophrenia
Los Angeles, California
Low social motivation is a significant symptom of schizophrenia and is a major cause of disability and suffering for many patients struggling with the illness. Social motivation refers to the drive to participate in or abstain from social activities. Many patients with schizophrenia evidence both decreased drive to seek positive social input (approach motivation) and heightened drive to avoid negative social input (avoidance motivation) compared to individuals without the illness. Despite the enormous burden of these deficits on patients, there are no medications that effectively treat impaired social motivation. Buprenorphine is an unusual drug that is used to treat opioid use disorder at higher doses and more recently, to treat depression and suicidality at lower doses. It is a unique opioid medication that has a compound action that gives it the potential to improve social motivation both by boosting approach motivation and by reducing avoidance motivation. The effects of low doses of buprenorphine have previously. been studied in healthy volunteers, showing that the drug enhances social motivation. These results in nonclinical volunteers suggest that buprenorphine may be a promising treatment for deficits in social motivation seen in some patients with schizophrenia. However, no previous studies have investigated the effects of buprenorphine on social motivation in this population. Here the effects of a low dose of buprenorphine (0.15mg) on social motivation in patients with schizophrenia (N=40) will be assessed. In this double-blind, cross-over, placebo-controlled study, participants will attend a 2-hour preparatory session and two 6-hour laboratory sessions, at which they will receive either placebo or buprenorphine. During expected peak drug effect they will complete validated tasks assessing social motivation. It is expected that buprenorphine will increase approach motivation and decrease avoidance motivation as measured by an attention bias task. The results of this study will lay the foundation for the clinical use of buprenorphine as the first medication to treat social deficits in schizophrenia.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Neurological, Cardiovascular, Respiratory, Others
Must Not Be Taking:Opioids, Sedatives, Benzodiazepines
40 Participants Needed
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