Effect of Vortioxetine on Cognitive Symptoms in Patients With Schizophrenia
Primary Purpose
Cognitive Deficit
Status
Unknown status
Phase
Early Phase 1
Locations
Croatia
Study Type
Interventional
Intervention
Vortioxetine
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Deficit
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 50, informed consent signed, confirmed diagnosis of schizophrenia, taking monotherapy with antipsychotics: aripiprazole, risperidone, paliperidone or olanzapine, unchanged dose maintenance back at least 6 months, remission of psychotic symptoms (PANSS ≤ 70), and that they do not have any of the exclusive criteria:
Exclusion Criteria:
- taking benzodiazepines at doses equivalent to ≥ 10 mg diazepam, taking mood stabilizers, antidepressants three months ago, abuse of addictions back three months, suicide attempt back 6 months, suicidal, heteroaggressive, or other similar behavior back 6 months, somatic comorbidities affecting cognitive functions (intellectual disabilities, significant neurological disease or head trauma), pregnancy
Sites / Locations
- University Hospital Centre ZagrebRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1group
2 group
Arm Description
patients with vortioxetine
patients without vortioxetine
Outcomes
Primary Outcome Measures
better cognitive functions
improvement of cognitive functions compared to initial examination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04456777
Brief Title
Effect of Vortioxetine on Cognitive Symptoms in Patients With Schizophrenia
Official Title
Effect of Vortioxetine on Cognitive Symptoms in Patients With
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alen Greš
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Research goals:
Examination of the relationship between the use of vortioxetine and cognitive efficacy in patients with schizophrenia.
Examination of the association between the use of vortioxetine and the presence depressive symptoms, physical and social anhedonia in patients with the disease from schizophrenia.
Examining the association between vortioxetine use and quality of life
(functional recovery) in patients with schizophrenia
Expected results (hypotheses)
Patients with schizophrenia treated with additional therapy vortioxetine will show better cognitive achievement in memory (short-term and long-term), attention, logical reasoning and reasoning, speed of information processing, processing of visual and sound information, language and speech in relation to patients without additional intervention.
Patients with schizophrenia treated with additional therapy vortioxetine will have a less pronounced presence of depressive symptoms, physical and social anhedonia in relation to untreated patients with additional vortioxetine therapy.
Patients with schizophrenia who were treated with additional therapy vortioxetine will have a better quality of life, ie. better functional recovery
Detailed Description
In the first phase of the research, the development of the research protocol and obtaining it will be done of his approval.
The second phase of the research will include patients with schizophrenia disorders based on inclusive and exclusive criteria and a study will be conducted procedure. In the third phase of the research, the obtained results are processed and analyzed.
The content of the dissertation will include an introduction, a goal with hypotheses, methods, results, discussion, conclusions and literature. In the introduction, in addition to current knowledge about schizophrenia and vortioxetine, it will be pointed out cognition problem in patients with schizophrenia.
It will be defined and explained hypotheses and research objectives. In the chapter dedicated to methodology, the number of respondents and a description will be presented study concepts, presentation of statistical methods used for data processing The presentation of the results obtained by this study will be presented textually, tabularly and using charts. The obtained results will be commented and evaluated in the Discussion. Recent literature will be used
Randomization 1:1 will divide 120 patients with schizophrenia into two groups, each group into 3 subgroups. One group of 60 patients (who are on monotherapy antipsychotics: new generations: 20 patients will be on olanzapine, 20 patients on risperidone and 20 patients on aripiprazole) will receive vortioxetine and the other control group of 60 patients (who is also on monotherapy with new antipsychotics generations: 20 patients will be on olanzapine, 20 patients on risperidone and 20 patients on aripiprazole) will not receive vortioxetine. Vortioxetine will be given in 10 mg dose (which can be reduced by 5 mg if needed in case of poor tolerability)
Initial examination:
International mini neuropsychiatric interview (M.I.N.I.) publicly available, works doctor General questionnaire - designed by a doctor Positive and negative syndrome scales (PANSS) are publicly available, by a doctor The Calgary Depression Scale for Schizophrenia (CDSS) is publicly available, it works doctor World Health Organization for Quality of Life (WHOQOL-BREF) publicly available, works doctor Chapman (social anhedonia and physical anhedonia) - publicly available, works doctor Wechsler WAIS IV (subtests: numerical memory test; encryption test symbols) - available at Naklada Slap, Zagreb, HR, by a clinical psychologist
Screening tests:
Mini-mental state (MMSE) or Folstein test - publicly available, by a doctor
Montreal Cognitive Assessment (MoCA) - publicly available, by a physician
At the end of the second month:
International mini neuropsychiatric interview (M.I.N.I.) publicly available, works doctor Mini-mental state (MMSE) or Folstein test - publicly available, by a doctor Montreal Cognitive Assessment (MoCA) - publicly available, by a doctor
At the end of the third month:
International mini neuropsychiatric interview (M.I.N.I.) publicly available, works doctor Positive and negative syndrome scales (PANSS) are publicly available, by a doctor The Calgary Depression Scale for Schizophrenia (CDSS) is publicly available, it works doctor World Health Organization for Quality of Life (WHOQOL-BREF) publicly available, works doctor Chapman (social anhedonia and physical anhedonia) - publicly available, works doctor Wechsler WAIS IV (subtests: numerical memory test; encryption test)
- Available at Naklada Slap, Zagreb, HR, by a clinical psychologist Screening tests: a) Mini-mental state (MMSE) or Folstein test - public
available, works doctor b) Montreal Cognitive Assessment (MoCA) - publicly available, by a doctor It is expected: improvement of cognitive functions in relation to the initial examination
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Deficit
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1group
Arm Type
Experimental
Arm Description
patients with vortioxetine
Arm Title
2 group
Arm Type
Placebo Comparator
Arm Description
patients without vortioxetine
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Intervention Description
vortioxetine will be administreted for 3 months
Primary Outcome Measure Information:
Title
better cognitive functions
Description
improvement of cognitive functions compared to initial examination
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age between 18 and 50, informed consent signed, confirmed diagnosis of schizophrenia, taking monotherapy with antipsychotics: aripiprazole, risperidone, paliperidone or olanzapine, unchanged dose maintenance back at least 6 months, remission of psychotic symptoms (PANSS ≤ 70), and that they do not have any of the exclusive criteria:
Exclusion Criteria:
taking benzodiazepines at doses equivalent to ≥ 10 mg diazepam, taking mood stabilizers, antidepressants three months ago, abuse of addictions back three months, suicide attempt back 6 months, suicidal, heteroaggressive, or other similar behavior back 6 months, somatic comorbidities affecting cognitive functions (intellectual disabilities, significant neurological disease or head trauma), pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alen Greš, MD
Phone
+385958845451
Email
alengres@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Šagud, prof, MD
Email
marinasagud@mail.com
Facility Information:
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Vortioxetine on Cognitive Symptoms in Patients With Schizophrenia
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