Glen Oaks, New York 11004


Purpose:

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.


Study 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. 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.


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)


NCT ID:

NCT02357797


Primary Contact:

Principal Investigator
Christoph U Correll, MD
North Shore LIJ

Christoph U Correll, MD
Phone: 718-470-4812
Email: ccorrell@nshs.edu


Backup Contact:

Email: eschenk@nshs.edu
Eva M Sheridan, MD
Phone: 718-470-4391


Location Contact:

Glen Oaks, New York 11004
United States

Christoph U Correll, MD
Phone: 718-470-4812
Email: ccorrell@nshs.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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