Effect of Vortioxetine on Cognitive Symptoms in Patients With Schizophrenia

NCT04456777 | Unknown Early Phase 1

• 1 other identifier: evcps
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Research goals:

1. 1.Examination of the relationship between the use of vortioxetine and cognitive efficacy in patients with schizophrenia.
2. 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. 3.Examining the association between vortioxetine use and quality of life
4. 4.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.
5. 5.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.
6. 6.Patients with schizophrenia who were treated with additional therapy vortioxetine will have a better quality of life, ie. better functional recovery

Conditions

Cognitive Deficit

Outcome Measures

Primary Outcomes (1)

• better cognitive functions

  improvement of cognitive functions compared to initial examination

  2 years

Study Arms (2)

1group

EXPERIMENTAL

patients with vortioxetine

Drug: Vortioxetine

2 group

PLACEBO COMPARATOR

patients without vortioxetine

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

vortioxetine will be administreted for 3 months

1group; 2 group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Alen Greš: lead

Study Sites (1)

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Cognition Disorders

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Alen Greš, MD

CONTACT

+385958845451; alengres@gmail.com

Marina Šagud, prof, MD

CONTACT

marinasagud@mail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Alen Greš,MD

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)