Cognitive DeficitEarly Phase 1NCT04456777
Effect of Vortioxetine on Cognitive Symptoms in Patients With Schizophrenia
A Early Phase 1 study testing Vortioxetine in people with Cognitive Deficit, run by Alen Greš at 1 site in Croatia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Deficit
- What is being tested?
- Vortioxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jul 2020to 1 Jul 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Marina Šagud, prof, MD contact
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Centre Zagreb
Zagreb, 10000
About this study
Official title: Effect of Vortioxetine on Cognitive Symptoms in Patients With
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
Read more
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
Read the 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
- Conditions
- Cognitive Deficit
- Being tested
- Vortioxetine
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
vortioxetine will be administreted for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1group | Experimental | patients with vortioxetine Receives: Drug: Vortioxetine |
| 2 group | Placebo comparator | patients without vortioxetine Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
better cognitive functions
improvement of cognitive functions compared to initial examination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alen Greš
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alen Greš, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456777
- Sponsor's protocol ID
- evcps
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vortioxetine on Cognitive Symptoms in Patients With
- ClinicalTrials.gov ID
- NCT04456777
- Acronym / sponsor ID
- evcps
- Conditions
- Cognitive Deficit
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alen GrešUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1group | Experimental | Drug: Vortioxetinepatients with vortioxetine |
| 2 group | Placebo comparator | Drug: Vortioxetinepatients without vortioxetine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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:
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetinevortioxetine will be administreted for 3 months | Drug | 1group, 2 group |
Primary outcome
better cognitive functions
Time frame: 2 years
improvement of cognitive functions compared to initial examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Šagud, prof, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vortioxetine in people with Cognitive Deficit, run by Alen Greš at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alen Greš, MD (+385958845451, alengres@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
better cognitive functions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.