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Adjunctive Vortioxetine in Schizophrenia (AVIS)

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ClinicalTrials.gov Identifier: NCT02357797
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Christoph U. Correll, MD, Northwell Health

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
Schizophrenia Negative Symptoms Drug: Vortioxetine Other: Placebo 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Vortioxetine in Schizophrenia
Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: Brintellix

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



Primary Outcome Measures :
  1. Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change in the general composite score on the MATRICS Consensus Cognitive Battery (MCCB) from baseline to endpoint [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357797


Contacts
Contact: Christoph U Correll, MD 718-470-4812 ccorrell@nshs.edu
Contact: Eva M Sheridan, MD 718-470-4391 eschenk@nshs.edu

Locations
United States, New York
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Contact: Christoph U Correll, MD    718-470-4812    ccorrell@nshs.edu   
Sponsors and Collaborators
Northwell Health
Takeda
Investigators
Principal Investigator: Christoph U Correll, MD North Shore LIJ

Responsible Party: Christoph U. Correll, MD, Professor of Psychiatry, Northwell Health
ClinicalTrials.gov Identifier: NCT02357797     History of Changes
Other Study ID Numbers: 14-465
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Vortioxetine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT3 Receptor Antagonists