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Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
Recruiting
Trial ID: NCT05110157
Purpose
The primary objective for this study is to evaluate the effect of adjunctive valbenazine
versus placebo on symptoms of schizophrenia in participants who have inadequate response to
antipsychotic treatment.
Official Title
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects With Schizophrenia
Stanford Investigator(s)
Melanie Lean
Clinical Assistant Professor, Psychiatry and Behavioral Sciences
Khalid Salaheldin, MD
Clinical Assistant Professor, Psychiatry and Behavioral Sciences
Eligibility
Inclusion Criteria:
• Participants must meet all of the following inclusion criteria:
1. Completed written informed consent.
2. At the time of signing the informed consent, participant must be ≥18 years of age
3. Medically confirmed diagnosis of schizophrenia as defined by the Diagnostic and
Statistical Manual of Mental Disorders (DSM-5).
4. The initial diagnosis of schizophrenia must be ≥1 year before the screening visit.
5. Plasma levels for at least 1 of the participant's antipsychotic medications must be
detectable by an available assay.
6. The participant is treated with a stable regimen antipsychotic medication.
7. Must meet all of the following criteria at the screening visit and Day 1:
- PANSS total score ≥70
- PANSS score of ≥4 on at least 1 of the following:
- P1 (delusions)
- P3 (hallucinations)
- P6 (suspiciousness)
- G9 (unusual thought content)
- CGI-S score ≥4
- Stable background antipsychotic medication dose between the screening visit and
Day 1
- Stable PANSS total score between the screening visit and Day 1
8. The participant is outpatient with stable symptomatology
9. The participant must have an adult informant (for example, a family member, relative,
partner, social worker, caseworker, residential facility staff, or nurse).
10. Female participants of childbearing potential must agree to use contraception
consistently from the screening visit until 30 days after the last dose of study drug
or final study visit, whichever is longer.
11. Male participants must agree to use contraception consistently from screening until 30
days after last dose of study treatment.
Exclusion Criteria:
- Participants will be excluded from the study if they meet any of the following
criteria:
1. Pregnant or breastfeeding or plans to become pregnant during the study. This
criterion must be reconfirmed prior to the first dose of study treatment on Day
1.
2. Known hypersensitivity to any component of the formulation of valbenazine.
3. Has history of treatment resistant schizophrenia.
4. Evidence of depression as measured by a Calgary Depression Scale for
Schizophrenia (CDSS) score ≥11 at the screening visit or Day 1.
5. Participants with any suicidal behavior or suicidal ideation within 6 months
before the screening visit or Day 1.
6. Diagnosis of moderate or severe substance use disorder within the 6 months before
the screening visit.
7. Have a clinically significant unstable medical condition within 60 days before
the screening visit in the judgement of the investigator or any laboratory value
outside the normal range that is considered by the investigator to be clinically
significant at the screening visit.
8. Prior (within 6 months of the screening visit) or concomitant use of any VMAT2
inhibitor.
Intervention(s):
drug: Placebo
drug: Valbenazine
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305