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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Negative Symptoms||Drug: Vortioxetine Other: Placebo||Phase 4|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Adjunctive Vortioxetine in Schizophrenia|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
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.
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.
- Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint [ Time Frame: 16 weeks ]
- Change in the general composite score on the MATRICS Consensus Cognitive Battery (MCCB) from baseline to endpoint [ Time Frame: 16 weeks ]
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
|Contact: Christoph U Correll, MDfirstname.lastname@example.org|
|Contact: Eva M Sheridan, MDemail@example.com|
|United States, New York|
|The Zucker Hillside Hospital||Recruiting|
|Glen Oaks, New York, United States, 11004|
|Contact: Christoph U Correll, MD 718-470-4812 firstname.lastname@example.org|
|Principal Investigator:||Christoph U Correll, MD||North Shore LIJ|