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Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
Recruiting
Trial ID: NCT03201757
Purpose
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
Associate Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology)
Khalid Salaheldin, MD
Clinical Assistant Professor, Psychiatry and Behavioral Sciences
Eligibility
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
Intervention(s):
drug: ALKS 3831
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305