Cognitive Deficit Clinical Trial
Official title:
Effect of Vortioxetine on Cognitive Symptoms in Patients With
Research goals:
1. Examination of the relationship between the use of vortioxetine and cognitive efficacy
in patients with schizophrenia.
2. 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.
3. Examining the association between vortioxetine use and quality of life
(functional recovery) in patients with schizophrenia
Expected results (hypotheses)
1. 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.
2. 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.
3. Patients with schizophrenia who were treated with additional therapy vortioxetine will
have a better quality of life, ie. better functional recovery
Status | Recruiting |
Enrollment | 120 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Centre Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
Alen Greš |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | better cognitive functions | improvement of cognitive functions compared to initial examination | 2 years |
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