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Adjunctive Vortioxetine in Schizophrenia (AVIS)

Primary Purpose

Schizophrenia, Negative Symptoms

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vortioxetine
Placebo
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Outpatient
  2. SCID diagnosis of schizophrenia
  3. Age 18-65 years old
  4. 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.
  5. No antidepressant treatment for at least 8 weeks prior to randomization.
  6. 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.
  7. PANSS Negative subscore >14 with at least two of the items at a level >/=4 (moderate)
  8. 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).
  9. HAMD-17 total score </=12
  10. Simpson Angus Score of any item <3
  11. English-speaking
  12. Competent and willing to sign informed consent

Exclusion Criteria:

  1. Structural brain disease
  2. Mental retardation by history and estimated IQ <70 (WRAT-III Word Reading)
  3. Autism-spectrum disorder diagnosis by history
  4. 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.
  5. Active substance abuse or dependence in the past 8 weeks
  6. Intolerance to or inefficacy of vortioxetine in the past
  7. Acute anger to self or others as per investigator assessment
  8. Pregnant or breastfeeding females
  9. Unwilling or unable to be sexually abstinent or not using an effective form of birth control if they are sexually active
  10. Current treatment with a Monoamine Oxidase Inhibitor (MAOI)

Sites / Locations

  • Henderson Behavioral Health
  • Cherry Health
  • The Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vortioxetine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint

Secondary Outcome Measures

Change in the general composite score on the MATRICS Consensus Cognitive Battery (MCCB) from baseline to endpoint

Full Information

First Posted
February 3, 2015
Last Updated
October 18, 2023
Sponsor
Northwell Health
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02357797
Brief Title
Adjunctive Vortioxetine in Schizophrenia
Acronym
AVIS
Official Title
Adjunctive Vortioxetine in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Negative Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Brintellix
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in the general composite score on the MATRICS Consensus Cognitive Battery (MCCB) from baseline to endpoint
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph U Correll, MD
Organizational Affiliation
North Shore LIJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henderson Behavioral Health
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Cherry Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

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Adjunctive Vortioxetine in Schizophrenia

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