Alkermes, Inc.: Schizophrenia trials

The registry lists 21 Schizophrenia studies with Alkermes, Inc. as lead sponsor. 3 are open to participants now and 13 have results posted.

Phase 1 4Phase 2 2Phase 3 12Phase 4 1No phase 2(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)AvailableNCT07744113
• Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I DisorderRecruitingNCT05303064Phase 3
• Long-term Safety Extension Study of OLZ/SAM in Pediatric SubjectsEnrolling by invitationNCT04987229Phase 3
• A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of SchizophreniaCompletedNCT03345979Phase 3Results posted
• Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831CompletedNCT03201757Phase 3Results posted
• Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I DisorderCompletedNCT03187769Phase 3Results posted
• A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With SchizophreniaCompletedNCT02873208Phase 3Results posted
• A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)CompletedNCT02694328Phase 3Results posted
• A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With SchizophreniaCompletedNCT02669758Phase 3Results posted
• A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)CompletedNCT02634346Phase 3Results posted
• A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With SchizophreniaCompletedNCT02634320Phase 4Results posted
• A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use DisorderCompletedNCT02161718Phase 2Results posted
• A Study of ALKS 3831 in Adults With SchizophreniaCompletedNCT01903837Phase 2Results posted
• An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)CompletedNCT01895452Phase 3Results posted
• A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)CompletedNCT01626456Phase 3Results posted
• A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With SchizophreniaCompletedNCT01469039Phase 3Results posted
• Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)CompletedNCT03919994
• A Phase 1 Safety Study in Adults With SchizophreniaCompletedNCT02804568Phase 1
• A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective DisorderCompletedNCT02636842Phase 1
• An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable SchizophreniaCompletedNCT02320032Phase 1
• A Study of ALKS 9072 in Subjects With Chronic Stable SchizophreniaCompletedNCT01493726Phase 1