Adjunctive Vortioxetine in Schizophrenia
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Northwell Health
- Enrollment
- 88
- Locations
- 3
- Primary Endpoint
- Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint
Study Overview
Brief Summary
This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88 stable patients with a research diagnosis of schizophrenia determined with the Structured Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining whether earlier illness moderates greater negative and /or cognitive symptom reduction in response to vortioxetine.
Detailed Description
This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88 stable patients with a research diagnosis of schizophrenia determined with the Structured Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining whether earlier illness moderates greater negative and /or cognitive symptom reduction in response to vortioxetine.
Patients with clinical stability for at least 3 months and stable antipsychotic and psychotropic medication treatment for at least the last 4 weeks and without relevant depression, positive psychotic symptoms or extrapyramidal symptoms EPS will be eligible. After written informed consent, patients will undergo a screening visit to confirm full study eligibility. If all in- and exclusion criteria are fulfilled, patients will undergo a baseline assessment and then be randomized 1:1 to 16 weeks of adjunctive treatment with vortioxetine or placebo. Subsequently, patients will be seen at week 1, 2, 4 and monthly for the next 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •SCID diagnosis of schizophrenia
- •Age 18-65 years old
- •Treated with an adequate dose of one or a maximum of two antipsychotic medications for at least 3 months, with a stable dose for at least the last 4 weeks, and willing to continue for up to 16 weeks.
- •No antidepressant treatment for at least 8 weeks prior to randomization.
- •Treatment with other concomitant, non-antipsychotic, psychiatric medications is allowed, but must be unchanged for at least 8 weeks, with a stable dose for at least the last 4 weeks, and willing to continue for 16 weeks. Benzodiazepines must not be given within 8 hours of the cognitive assessment. Treatment with non-psychiatric medications is unrestricted.
- •PANSS Negative subscore >14 with at least two of the items at a level >/=4 (moderate)
- •PANSS Positive subscore </=14 with not more than one of the items at a level >/=4 (moderate) for patients who have been stable outpatients for <1 year. A PANSS Positive subscore of </=18 is acceptable for patients who have been stable outpatients for >/=1year and whose psychotic symptoms do not affect behavior in a clinically relevant way as per investigator assessment. - . In order to avoid simple double counting, any rating on P1 ("delusions") will not be considered as an additional symptom for determination of eligibility based on PANSS positive subscore when a specific delusion is present that is rated either on P5 ("grandiosity") or P6 ("suspiciousness/paranoia"), whereas delusions not captured by P5 ("grandiosity") or P6 ("suspiciousness/paranoia"), will be rated under P1 ("delusions") and counted toward the sum score used to determine study eligibility).
- •HAMD-17 total score </=12
- •Simpson Angus Score of any item <3
- •English-speaking
- •Competent and willing to sign informed consent
Exclusion Criteria
- •Structural brain disease
- •Mental retardation by history and estimated IQ <70 (WRAT-III Word Reading)
- •Autism-spectrum disorder diagnosis by history
- •Any serious chronic medical illnesses that in the view of the investigator will interfere with the patient's ability to comply with the study procedures or that will interfere with cognition.
- •Active substance abuse or dependence in the past 8 weeks
- •Intolerance to or inefficacy of vortioxetine in the past
- •Acute anger to self or others as per investigator assessment
- •Pregnant or breastfeeding females
- •Unwilling or unable to be sexually abstinent or not using an effective form of birth control if they are sexually active
- •Current treatment with a Monoamine Oxidase Inhibitor (MAOI)
Arms & Interventions
Vortioxetine
Vortioxetine will be initiated at 10 mg / day for 1 month, followed by 20 mg /day for the remainder of the trial. The dose of vortioxetine can be lowered to 10 mg for tolerability reasons.
Intervention: Vortioxetine (Drug)
Placebo
Matching placebo pills will be initiated at 10 mg / day for 1 month, followed by 20 mg /day for the remainder of the trial. The dose of placebo can be lowered to 10 mg for tolerability reasons.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint
Time Frame: 16 weeks
Secondary Outcomes
- Change in the general composite score on the MATRICS Consensus Cognitive Battery (MCCB) from baseline to endpoint(16 weeks)
Investigators
Christoph U. Correll, MD
Professor of Psychiatry
Northwell Health