Cognitive Impairment With Primary Psychotic DisorderPhase 2/3CAVESNCT04895488
Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
A Phase 2/3 study testing Vortioxetine and Usual Antipsychotic Treatment in people with Cognitive Impairment With Primary Psychotic Disorder and Negative Symptoms With Primary Psychotic Disorder, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cognitive Impairment With Primary Psychotic Disorder, Negative Symptoms With Primary Psychotic Disorder
- What is being tested?
- Vortioxetine and Usual Antipsychotic Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2022to 20 Dec 2025
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
- Simpson Angus Score of any item <2
- Behaviorally Anchored Rating Scale (BARS) of any item </= 1
- Competent and willing to sign informed consent
- The patient, if a woman, must: agree not to try to become pregnant during the study and use adequate, highly effective contraception
Who cannot join
- 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)
- 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.
Show all 10Show fewer
- Serious risk of suicide.
- Patients with thyroid conditions.
- Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded.
- Pregnant or breastfeeding female.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Benedicto Crespo Facorro, Professor, +34671596675, benedicto.crespo.sspa@juntadeandalucia.es
Idalino Rocha, MSc, +34689366067, idalino.rocha@juntadeandalucia.es
About this study
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.
Read the detailed description
Clinical trial to assess the efficacy of Vortioxetine, compared with treatment as usual in early schizophrenia. Propose: To investigate the effect of Vortioxetine in cognitive functioning and negative symptoms severity in early schizophrenia.
- Conditions
- Cognitive Impairment With Primary Psychotic Disorder, Negative Symptoms With Primary Psychotic Disorder
- Being tested
- Vortioxetine, Usual Antipsychotic Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
First treatment phase: vortioxetine will be initiated at 10 mg / day for 2 weeks, followed by 20 mg /day for 22 weeks. The dose of vortioxetine can be lowered to 5 mg or 10 mg for tolerability reasons at clinician criteria.
Wash-out period 2 weeks
Usual Antipsychotic TreatmentDrug
Also called TAU
Second treatment phase. Usual antipsychotic treatment for 26 weeks: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Vortioxetine+Usual antipsychotic treatment (TAU) | Experimental | Drug:
First treatment phase: Vortioxetine 10 mg 1 tablet/d for 2 weeks added to Usual antipsychotic treatment, followed by Vortioxetine 20mg 1tablet/d for 22 weeks added to Usual antipsychotic treatment.
Wash-out period 2 weeks Receives: Drug: Vortioxetine; Drug: Usual Antipsychotic Treatment |
| Arm B: Usual antipsychotic treatment (TAU) | Active comparator | Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician. Receives: Drug: Vortioxetine; Drug: Usual Antipsychotic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change From Baseline to Week 24 in BACS App scores using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores
Measured: Baseline, week 24, week 26 and week 50
Secondary outcomes (1)
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Negative Symptoms severity (Scale for Assessment of Negative Symptoms (SANS) and Negative Symptom Assessment-4 (NSA-4) total scores)
To assess the effectiveness of Vortioxetine vs. TAU in the treatment of negative symptoms in early psychosis, measured by the change in Negative Symptoms severity (SANS, NSA-4 total scores) from baseline to end of trial.
Measured: Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start20 Jan 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment With Primary Psychotic DisorderStudies 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A two arm, Open-label, randomized, Cross-over Design and single-center clinical trial Phase II b /Phase III.
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benedicto Crespo Facorro, Professor, Principal investigator, benedicto.crespo.sspa@juntadeandalucia.es
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895488
- Sponsor's protocol ID
- CAVES
- Other IDs
- 2021-001333-38
- Acronym
- CAVES
- Status last verified
- Feb 2024
- First submitted
- 17 May 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
- ClinicalTrials.gov ID
- NCT04895488
- Acronym / sponsor ID
- CAVES / CAVES
- Conditions
- Cognitive Impairment With Primary Psychotic Disorder, Negative Symptoms With Primary Psychotic Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 20 May 2021 (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.
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.
Detailed description
Clinical trial to assess the efficacy of Vortioxetine, compared with treatment as usual in early schizophrenia. Propose: To investigate the effect of Vortioxetine in cognitive functioning and negative symptoms severity in early schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two arm, Open-label, randomized, Cross-over Design and single-center clinical trial Phase II b /Phase III.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Vortioxetine+Usual antipsychotic treatment (TAU) | Experimental | Drug: Vortioxetine, Drug: Usual Antipsychotic TreatmentDrug: First treatment phase: Vortioxetine 10 mg 1 tablet/d for 2 weeks added to Usual antipsychotic treatment, followed by Vortioxetine 20mg 1tablet/d for 22 weeks added to Usual antipsychotic treatment. Wash-out period 2 weeks |
| Arm B: Usual antipsychotic treatment (TAU) | Active comparator | Drug: Vortioxetine, Drug: Usual Antipsychotic TreatmentSecond treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
- 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.
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 |
|---|---|---|
| VortioxetineFirst treatment phase: vortioxetine will be initiated at 10 mg / day for 2 weeks, followed by 20 mg /day for 22 weeks. The dose of vortioxetine can be lowered to 5 mg or 10 mg for tolerability reasons at clinician criteria. Wash-out period 2 weeks | Drug | Arm A: Vortioxetine+Usual antipsychotic treatment (TAU), Arm B: Usual antipsychotic treatment (TAU) |
| Usual Antipsychotic TreatmentAlso: TAUSecond treatment phase. Usual antipsychotic treatment for 26 weeks: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician. | Drug | Arm A: Vortioxetine+Usual antipsychotic treatment (TAU), Arm B: Usual antipsychotic treatment (TAU) |
Primary outcome
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
Time frame: Baseline, week 24, week 26 and week 50
To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change From Baseline to Week 24 in BACS App scores using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores
1 secondary outcome
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Negative Symptoms severity (Scale for Assessment of Negative Symptoms (SANS) and Negative Symptom Assessment-4 (NSA-4) total scores)
Time frame: Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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.
Benedicto Crespo Facorro, Professor principal investigator
benedicto.crespo.sspa@juntadeandalucia.es
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vortioxetine and Usual Antipsychotic Treatment in people with Cognitive Impairment With Primary Psychotic Disorder and Negative Symptoms With Primary Psychotic Disorder, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 12 inclusion and 10 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 26 Feb 2024. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Clara M. Rosso Fernández, PhD (+34 955 013414, claram.rosso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores (time frame: Baseline, week 24, week 26 and week 50). 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 26 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.