Adjunctive Vortioxetine in Schizophrenia

NCT02357797 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 14-645
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

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.

Conditions

Schizophrenia; Negative Symptoms

Outcome Measures

Primary Outcomes (1)

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

  16 weeks

Secondary Outcomes (1)

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

  16 weeks

Study Arms (2)

Vortioxetine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Vortioxetine DRUG

Also known as: Brintellix

Vortioxetine

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwell Health: lead
• Takeda: collaborator

Study Sites (3)

Henderson Behavioral Health

Lauderdale Lakes, Florida, 33319, United States

Location

Cherry Health

Grand Rapids, Michigan, 49503, United States

Location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christoph U Correll, MD

  North Shore LIJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2023
• Study Completion: June 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

US (3)