Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831


Trial ID: NCT03201757


This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Official Title

A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

Stanford Investigator(s)

Jacob S. Ballon
Jacob S. Ballon

Associate Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology)

Khalid Salaheldin, MD

Clinical Assistant Professor, Psychiatry and Behavioral Sciences


Inclusion Criteria:

   - Willing and able to give informed consent/assent as per local requirements

   - Agrees to use an acceptable method of contraception during the study, and for 30 days
   after any study drug administration, unless surgically sterile or post-menopausal

   - Has the potential to benefit from the administration of ALKS 3831, in the opinion of
   the investigator

   - Subject met the eligibility criteria of the antecedent study at the time of enrollment
   in the antecedent study and completed the treatment period in one of the following
   antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307

   - Additional criteria may apply

Exclusion Criteria:

   - Has any finding that, in the view of the investigator or medical monitor, would
   compromise the safety of the subject or affect their ability to fulfill the protocol
   visit schedule or visit requirements

   - Has a positive drug screen for drugs of abuse at study entry

   - Currently pregnant or breastfeeding or is planning to become pregnant during the study
   or within 30 days of the last study drug administration

   - Additional criteria may apply


drug: ALKS 3831


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305