Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia (NCT04895488) | Clinical Trial Compass
UnknownPhase 2/3
Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
Spain37 participantsStarted 2022-01-20
Plain-language summary
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Outpatient
. Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM - SCID) diagnosis of Schizophrenia spectrum disorders.
. Age \>18-50 years old
. Stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine).
. No antidepressant treatment for at least 8 weeks prior to randomization.
. PANSS Negative subscore \>14 with at least two of the items at a level \>/=4 (moderate)
. PANSS Positive subscore \</=14 with not more than one of the items at a level \>/=4 (moderate)
. Hamilton Depression Rating Scale (HAMD-17) total score \</=12
Exclusion criteria
. Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization.
. Structural brain disease (based on previous medical records)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
Timeframe: Baseline, week 24, week 26 and week 50
Trial details
NCT IDNCT04895488
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
. Cognitive disability by history and estimated intelligence quotient (IQ) \<70 (ID DSM-5 diagnosis).
. Any serious chronic medical illnesses that may interfere with the patient's ability to comply with the study procedures or that will interfere with cognition.
. Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders.
. Any current diagnosis of substance abuse or dependence.