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48 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 PowerML-007C-MA for Alzheimer's Disease Psychosis
Anaheim, California
ML-007C-MA-221 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP).
The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Hospice Care, Substance Abuse, CNS Disorder, Depression, Others
300 Participants Needed
KYN-5356 for Schizophrenia
Los Alamitos, California
This is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of 3 different dose regiments of KYN-5356 and placebo for 28 days.
Participants will be randomized to one of 4 treatment groups: placebo, KYN-5356 low dose, KYN-5356 medium dose, KYN-5356 high dose.
Participants will be admitted to the clinic on Day -3 and will remain in residence at the clinic for 32 days, from baseline through the treatment period.
Participants will be administered investigational medicinal product on Days 1 through 28. Efficacy, safety, PK and exploratory PD assessments will be performed throughout the dosing period. Participants will be discharged on Day 29 after safety assessments are completed and return for a follow-up visit on Day 42.
A subset of participants from selected sites will undergo electrophysiological assessments to evaluate the effect of KYN-5356 on neurophysiological measures of brain function.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Unstable Condition, Others
Must Be Taking:Antipsychotics
150 Participants Needed
KarXT for Schizophrenia
Los Alamitos, California
The purpose of this study is to evaluate the dose levels, safety, and drug levels of KarXT intramuscular injection in participants with Schizophrenia
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:New Schizophrenia, Major Depression, Others
Must Not Be Taking:Antipsychotics
48 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
Evenamide for Treatment-Resistant Schizophrenia
Los Angeles, California
This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Suicidal Risk, Epilepsy, Others
Must Be Taking:Antipsychotics
400 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
Iloperidone for Schizophrenia
Oceanside, California
The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Other Psychiatric Disorders, Others
Must Be Taking:Iloperidone
400 Participants Needed
Mobile Therapy for Mental Illness in Homeless-Experienced Veterans
West Los Angeles, California
This study aims to test the feasibility and acceptability of a brief behavioral intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), that have been shown to work in prior research studies. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone (together called MI-CBTech). The goal of the intervention is to improve community integration in Veterans with serious mental illness (SMI) who have experienced homelessness. A time- and format-matched control arm will include remote mindfulness training. 50 Veterans with SMI experiencing homelessness will be randomized to one of the two arms (25 per arm).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Neurological Disorder, Head Injury, IQ < 70, Substance Use, Others
50 Participants Needed
Luteolin for Schizophrenia
Los Angeles, California
This trial tests if luteolin, a natural substance found in some foods, can help people with schizophrenia who still have symptoms and cognitive issues. Luteolin might improve brain function by reducing inflammation and protecting brain cells.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Substance Misuse, Infection, Pregnancy, Others
Must Be Taking:Antipsychotics
60 Participants Needed
Collaborative Decision Skills Training for Serious Mental Illness
West Los Angeles, California
Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and/or have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Use, Neurological Disorder, Violence, Others
119 Participants Needed
Clozapine for Schizophrenia
Los Angeles, California
This trial is testing whether clozapine can reduce violent behavior more effectively than usual treatments in adults with schizophrenia who have recently been violent. Clozapine helps by balancing brain chemicals to manage symptoms. The study will last for several months and include regular medical check-ups. Clozapine has been shown to reduce violent and aggressive behavior in patients with schizophrenia, especially those who are treatment-resistant.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Unstable Medical Condition, Pregnancy, Suicide Risk, Others
Must Be Taking:Antipsychotics
280 Participants Needed
Telehealth Aerobic Exercise & Cognitive Training for Schizophrenia
Los Angeles, California
The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition. The primary outcome measures are improvement in cognition and level of engagement in the in-group and at-home exercise sessions. Increases in the level of the patient's serum brain-derived neurotropic factor (specifically Mature BDNF) which causes greater brain neuroplasticity and is indicator of engagement in aerobic exercise, will be measured early in the treatment phase in order to confirm engagement of this target. In order to demonstrate the feasibility and portability of this intervention outside of academic research programs, the interventions will be provided via videoconferencing. The proposed study will incorporate additional methods to maximize participation in the exercise condition, including the use of the Moderated Online Social Therapy (MOST) platform to enhance motivation for treatment based on Self-Determination Theory principles, and a "bridging" group to help the participants generalize gains to everyday functioning. In addition, the exercise group participants will receive personally tailored text reminders to exercise.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Neurological Disorder, Substance Use, Others
100 Participants Needed
Why Other Patients Applied
"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
"I’ve been treated over the years from my late teens. I’ve been through many therapists for my bipolar and my anxiety. None of it’s helped. I gave up when I was 27. It’s been 5 years of struggling day by day. My fiancé has finally suggested I look into trying to get help so I’m hoping this clinical trial will help."
WZ
Schizophrenia PatientAge: 32
"I've tried many medications that didn't work that well. I really really want to be better and function in society... a different kind of treatment could help."
FF
Schizophrenia PatientAge: 36
"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 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
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