Phase 1 Schizophrenia Clinical Trials
21 recruitingPhase 1
What is a Phase 1 trial?
Phase 1 trials test a new treatment in a small group of people for the first time. The primary goal is to evaluate safety, determine a safe dosage range, and identify side effects. These studies typically enroll 20 to 80 participants.
Showing 1–20 of 21 trials
Recruiting
Phase 1
A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
Schizophrenia
Bristol-Myers Squibb116 enrolled8 locationsNCT07061288
Recruiting
Phase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Janssen Research & Development, LLC64 enrolled8 locationsNCT07615426
Recruiting
Phase 1
The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia.
Schizophrenia Disorders
Sichuan Kelun Pharmaceutical Co., Ltd56 enrolled1 locationNCT06674694
Recruiting
Phase 1
Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119
Schizophrenia
Vigonvita Life Sciences40 enrolled4 locationsNCT06504290
Recruiting
Phase 1Phase 2
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
SchizophreniaMajor Depressive DisorderBipolar I Disorder
Mapi Pharma Ltd.24 enrolled6 locationsNCT07185815
Recruiting
Phase 1
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
SchizophreniaSchizo Affective DisorderBipolar Disorder I+2 more
BioXcel Therapeutics Inc140 enrolled5 locationsNCT05025605
Recruiting
Phase 1Phase 2
Acetazolamide for Treatment Resistant Schizophrenia
SchizophreniaSchizo Affective Disorder
Vishwajit Nimgaonkar, MD PhD60 enrolled2 locationsNCT04887792
Recruiting
Phase 1Phase 2
Ocrelizumab for Psychosis by Autoimmunity
SchizophreniaSchizo-Affective Type of Psychosis
The Methodist Hospital Research Institute40 enrolled1 locationNCT03971487
Recruiting
Phase 1Phase 2
Tolerability of MDMA in Schizophrenia
Schizophrenia
Anya Bershad, MD, PhD20 enrolled1 locationNCT05770375
Recruiting
Phase 1Phase 2
Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
SchizophreniaSchizo Affective Disorder
Vishwajit Nimgaonkar, MD PhD160 enrolled1 locationNCT03794076
Recruiting
Phase 1
A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
SchizophreniaAlzheimer's Disease Psychosis
Luye Pharma Group Ltd.40 enrolled1 locationNCT07230652
Recruiting
Phase 1
Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans
SchizophreniaCannabis Use Disorder
Yale University215 enrolled1 locationNCT06058702
Recruiting
Phase 1
Study of the Safety, Tolerability, Pharmacokinetics and Food Effects of VV119 Capsules in Chinese Healthy Volunteers
Schizophrenia
Vigonvita Life Sciences82 enrolled1 locationNCT06105151
Recruiting
Phase 1
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
Schizophrenia
University of Arizona24 enrolled1 locationNCT03781115
Recruiting
Phase 1
Alexithymia Intervention for Suicide
SchizophreniaPost Traumatic Stress DisorderSuicide+2 more
VA Office of Research and Development40 enrolled1 locationNCT05724953
Recruiting
Phase 1
Imaging Synapses With [11C] UCB-J in the Human Brain
Schizophrenia
Davidzon, Guido, M.D.60 enrolled2 locationsNCT04038840
Completed
Phase 1
Comparative assessment of the absorption of a generic formulation of 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral suspension against the innovator 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral tablet conducted under fasting conditions in healthy male and female volunteers.
3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine is indicated for treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics.
Zenith Technology Corporation Limited28 enrolled1 locationACTRN12621001490864
Withdrawn
Phase 1
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Risperidone Extended Release Capsules in Patients with Schizophrenia, Schizoaffective Disorder or Bipolar 1 Disorder
Schizophrenia
Lyndra Australia Pty Ltd8 enrolled1 locationACTRN12619001569190
Completed
Phase 1
A placebo and comparator controlled phase 1, safety and tolerability study of 3 ascending doses of INP105 (intranasal OLZ by I231 POD® device).
Acute Agitation in SchizophreniaAcute Agitation in Bipolar I Disorder
Clinical Network Services (CNS) Pty Ltd36 enrolled1 locationACTRN12618000966291
Completed
Phase 1
Open-Label Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114)
SchizophreniaBipolar Disorder IAutistic Disorder
Delpor Australia Pty Ltd17 enrolled1 locationACTRN12617001251314