Adjunctive Vortioxetine in Schizophrenia

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Negative Symptoms

In brief

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.

Key facts

Study ID

NCT02357797

Run by

Northwell Health

People needed

88

Starts

2016-02-01

Expected to finish

2024-06-01

Last updated by the study team

2024-02-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Henderson Behavioral Health — Lauderdale Lakes, Florida, United States
• Cherry Health — Grand Rapids, Michigan, United States
• The Zucker Hillside Hospital — Glen Oaks, New York, United States

Full record on ClinicalTrials.gov

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