AVIS: Adjunctive Vortioxetine in Schizophrenia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Drug: Vortioxetine
Other Names:
|
| Placebo Comparator: 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. |
Other: Placebo
|
Outcome Measures
Primary Outcome Measures
- Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint [16 weeks]
Secondary Outcome Measures
- Change in the general composite score on the MATRICS Consensus Cognitive Battery (MCCB) from baseline to endpoint [16 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Outpatient
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Henderson Behavioral Health | Lauderdale Lakes | Florida | United States | 33319 |
| 2 | Cherry Health | Grand Rapids | Michigan | United States | 49503 |
| 3 | The Zucker Hillside Hospital | Glen Oaks | New York | United States | 11004 |
Sponsors and Collaborators
- Northwell Health
- Takeda
Investigators
- Principal Investigator: Christoph U Correll, MD, North Shore LIJ
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-465