SchizophreniaPhase 4PAFIP3_nc3YNCT03883204
Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: 3-years Follow-up
A Phase 4 study testing Aripiprazole and Risperidone in people with Schizophrenia and Psychotic Disorders, run by Fundación Marques de Valdecilla at 1 site in Spain.
Trial summary
Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive deficits are already present at the first break of the illness, seem to remain stable during early phases and noticeably influence daily functioning. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychotic Disorders, Psychosis
- What is being tested?
- Aripiprazole and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2015to Dec 2020
- Phase
- Phase 4
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients followed in the First Episode Psychosis Clinical Program (PAFIP III) from January 2015 to December 2020.
- Experiencing their first episode of psychosis (First Episode of Psychosis is defined as that psychopathological state in which for the first time and regardless of its duration, the patient has enough severe psychotic symptoms to allow a diagnosis of psychosis, having received no specific psychiatric treatment for him).
- Living in the catchment area (Cantabria).
- No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder.
Who cannot join
- Meeting DSM-IV criteria for drug dependence.
- Meeting DSM-IV criteria for mental retardation.
- Having a history of neurological disease or head injury with loss of consciousness.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital Marques de Valdecilla
Santander, Cantabria, 39008
About this study
Official title: Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: a Randomized Comparison of Aripiprazole and Risperidone Over 3 Years
Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive deficits are already present at the first break of the illness, seem to remain stable during early phases and noticeably influence daily functioning. Differences among antipsychotics in terms of cognitive effectiveness have turned out to be a topic of increasing research interest. The initially postulated superior neurocognitive effectiveness of second-generation antipsychotics (SGAs) compared to first-generation antipsychotics (FGAs) is currently under debate. Long-term studies would be of great value to evaluate the differential benefits exerted by antipsychotic drugs on cognitive performance. The aim of this study is to investigate the cognitive effects of aripiprazole and risperidone in first-episode psychosis at 3 years.
Read the detailed description
Study setting and financial support: data for the present investigation were obtained from an ongoing epidemiological and three-year longitudinal intervention program of first-episode psychosis (PAFIP) conducted at the outpatient clinic and the inpatient unit at the University Hospital Marqués de Valdecilla, Spain. Conforming to international standards for research ethics, this program was approved by the local institutional review board. Patients meeting inclusion criteria and their families provided written informed consent to be included in the PAFIP. The Mental Health Services of Cantabria provided funding for implementing the program. No pharmaceutical company supplied any financial support.
Study design: this is a flexible-dose study of two neuroleptics (Aripiprazole and Risperidone) assigned at aleatory ratio 1:1. Rapid titration schedule (5-day), until optimal dose is reached, is a rule used unless severe side effects occur. At the treating physician's discretion, the dose and type of antipsychotic medication could be changed based on clinical efficacy and the profile of side effects during the follow-up period. Antimuscarinic medication, Lormetazepam and Clonazepam are allowed for clinical reasons. No antimuscarinic agents are administered prophylactically. Antidepressants (Sertraline) and mood stabilizers (lithium) are permitted if clinically needed.
Clinical assessment: the severity scale of the Clinical Global Impression (CGI) scale, the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Positive symptoms (SAPS), the Scale for the Assessment of Negative symptoms (SANS), the Calgary Depression Scale for Schizophrenia (CDSS) and the Young Mania Rating Scale (YMRS) were used to evaluate symptomatology. To assess general adverse event experiences, the Scale of the Udvalg for Kliniske Undersogelser (UKU), the Simpson-Angus Rating Scale (SARS) and the Barnes Akathisia Scale (BAS) were used. The same trained psychiatrist (BC-F) completed all clinical assessments. These clinical data are described at AZQ2005 study.
Neuropsychological assessment. Cognitive functioning was assessed in patients at 2 points: baseline and 3 years after the initialization of antipsychotic treatment. The cognitive assessment at baseline was carried out at 12 weeks after recruitment because this time is considered optimal for patients' stabilization. The evaluation required approximately 2 h and was carried out in the same day by the same neuropsychologist (R.A.-A and E.G.-R). The neuropsychological battery comprises 9 cognitive domains: information processing speed, motor dexterity, working memory, verbal learning, visuospatial abilities, delayed memory, attention, executive function and theory of mind.
- Conditions
- Schizophrenia, Psychotic Disorders, Psychosis
- Being tested
- Aripiprazole, Risperidone
- Keywords
- Cognition, Antipsychotic Agents, Treatment, Effectiveness, Aripiprazole, Risperidone
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
Initial dose: 10 mg.
RisperidoneDrug
Also called Risperdal
Initial dose: 2 mg.
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Active comparator | Oral, dose range 10-30 mg/day, once or twice a day during study duration. Receives: Drug: Aripiprazole |
| Risperidone | Active comparator | Oral, dose range 1-6 mg/day, once or twice a day during study duration. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive index
In order to calculate a measure of Global Cognitive Functioning (GCF) raw cognitive scores were reversed when appropriate before standardization so they all have the same direction (the higher, the better). According to previous methodology, the GCF was calculated as T-scores, with raw scores of a healthy comparison sample. T scores were converted to deficit scores that reflect presence and severity of cognitive impairment. Deficit scores on all tests were then "averaged" to create the GCF score.
Measured: 3 years
Secondary outcomes (17)
Change in information processing speed
Measured by Wechsler Adult Intelligence Scale (WAIS)-III digit symbol subtest (standard total score).
Measured: 3 years
Change in information processing speed
Measured by Trail Making Test (TMT) trail A.
Measured: 3 years
Change in information processing speed
Measured by Continuoys Performace Test (CPT) reaction time.
Measured: 3 years
Change in motor dexterity
Measured by Grooved Pegboard Test (time to complete with dominant hand).
Measured: 3 years
Change in working memory
Measured by WAIS-III letter-number sequencing test (standard total score).
Measured: 3 years
Change in working memory
Measured by WAIS-III digits forward (standard total score).
Measured: 3 years
Change in verbal learning
Measured by the Rey Auditory Verbal Learning Test (RAVLT) (trials 1-5).
Measured: 3 years
Change in visuospatial abilities
Measured by the Rey Complex Figure (RCF) (copy figure).
Measured: 3 years
Change in delayed memory
Measured by the Rey Auditory Verbal Learning Test (RAVLT) (list recall and list recognition discrimination subscore).
Measured: 3 years
Change in delayed memory
Measured by the Rey Complex Figure (RCF) (delayed recall).
Measured: 3 years
Change in attention
Measured by Continuoys Performace Test (CPT) (discrimination subscores).
Measured: 3 years
Change in executive function
Measured by Trail Making Test (TMT) trail B.
Measured: 3 years
Change in executive function
Measured by Stroop Test (color-word).
Measured: 3 years
Change in executive function
Measured by the Zoo Map Test (first and second conditions).
Measured: 3 years
Change in executive function
Measured by the Tower of London Test (ToL) (total correct and total moves score).
Measured: 3 years
Change in executive function
Measured by FAS Word Fluency and semantic (animal) fluency tests.
Measured: 3 years
Change in theory of mind
Measured by Eyes Task (total correct score).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Jan 2015
- Primary completion1 Dec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Marques de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
- Responsible party
- Principal investigator, Benedicto Crespo-Facorro, Fundación Marques de Valdecilla
- Investigators
- Benedicto Crespo-Facorro, Professor, Principal investigator, University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Santander, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883204
- Sponsor's protocol ID
- ROAC2018_nc3Y
- Acronym
- PAFIP3_nc3Y
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: a Randomized Comparison of Aripiprazole and Risperidone Over 3 Years
- ClinicalTrials.gov ID
- NCT03883204
- Acronym / sponsor ID
- PAFIP3_nc3Y / ROAC2018_nc3Y
- Conditions
- Schizophrenia, Psychotic Disorders, Psychosis
- Keywords
- Cognition, Antipsychotic Agents, Treatment, Effectiveness, Aripiprazole, Risperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Fundación Marques de ValdecillaUniversity, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Mar 2019 (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.
Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive deficits are already present at the first break of the illness, seem to remain stable during early phases and noticeably influence daily functioning. Differences among antipsychotics in terms of cognitive effectiveness have turned out to be a topic of increasing research interest. The initially postulated superior neurocognitive effectiveness of second-generation antipsychotics (SGAs) compared to first-generation antipsychotics (FGAs) is currently under debate. Long-term studies would be of great value to evaluate the differential benefits exerted by antipsychotic drugs on cognitive performance. The aim of this study is to investigate the cognitive effects of aripiprazole and risperidone in first-episode psychosis at 3 years.
Detailed description
Study setting and financial support: data for the present investigation were obtained from an ongoing epidemiological and three-year longitudinal intervention program of first-episode psychosis (PAFIP) conducted at the outpatient clinic and the inpatient unit at the University Hospital Marqués de Valdecilla, Spain. Conforming to international standards for research ethics, this program was approved by the local institutional review board. Patients meeting inclusion criteria and their families provided written informed consent to be included in the PAFIP. The Mental Health Services of Cantabria provided funding for implementing the program. No pharmaceutical company supplied any financial support.
Study design: this is a flexible-dose study of two neuroleptics (Aripiprazole and Risperidone) assigned at aleatory ratio 1:1. Rapid titration schedule (5-day), until optimal dose is reached, is a rule used unless severe side effects occur. At the treating physician's discretion, the dose and type of antipsychotic medication could be changed based on clinical efficacy and the profile of side effects during the follow-up period. Antimuscarinic medication, Lormetazepam and Clonazepam are allowed for clinical reasons. No antimuscarinic agents are administered prophylactically. Antidepressants (Sertraline) and mood stabilizers (lithium) are permitted if clinically needed.
Clinical assessment: the severity scale of the Clinical Global Impression (CGI) scale, the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Positive symptoms (SAPS), the Scale for the Assessment of Negative symptoms (SANS), the Calgary Depression Scale for Schizophrenia (CDSS) and the Young Mania Rating Scale (YMRS) were used to evaluate symptomatology. To assess general adverse event experiences, the Scale of the Udvalg for Kliniske Undersogelser (UKU), the Simpson-Angus Rating Scale (SARS) and the Barnes Akathisia Scale (BAS) were used. The same trained psychiatrist (BC-F) completed all clinical assessments. These clinical data are described at AZQ2005 study.
Neuropsychological assessment. Cognitive functioning was assessed in patients at 2 points: baseline and 3 years after the initialization of antipsychotic treatment. The cognitive assessment at baseline was carried out at 12 weeks after recruitment because this time is considered optimal for patients' stabilization. The evaluation required approximately 2 h and was carried out in the same day by the same neuropsychologist (R.A.-A and E.G.-R). The neuropsychological battery comprises 9 cognitive domains: information processing speed, motor dexterity, working memory, verbal learning, visuospatial abilities, delayed memory, attention, executive function and theory of mind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Active comparator | Drug: AripiprazoleOral, dose range 10-30 mg/day, once or twice a day during study duration. |
| Risperidone | Active comparator | Drug: RisperidoneOral, dose range 1-6 mg/day, once or twice a day during study duration. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients followed in the First Episode Psychosis Clinical Program (PAFIP III) from January 2015 to December 2020.
- Experiencing their first episode of psychosis (First Episode of Psychosis is defined as that psychopathological state in which for the first time and regardless of its duration, the patient has enough severe psychotic symptoms to allow a diagnosis of psychosis, having received no specific psychiatric treatment for him).
- Living in the catchment area (Cantabria).
- No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder.
Key exclusion criteria (3 listed)
- Meeting DSM-IV criteria for drug dependence.
- Meeting DSM-IV criteria for mental retardation.
- Having a history of neurological disease or head injury with loss of consciousness.
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 |
|---|---|---|
| AripiprazoleAlso: AbilifyInitial dose: 10 mg. | Drug | Aripiprazole |
| RisperidoneAlso: RisperdalInitial dose: 2 mg. | Drug | Risperidone |
Primary outcome
Global cognitive index
Time frame: 3 years
In order to calculate a measure of Global Cognitive Functioning (GCF) raw cognitive scores were reversed when appropriate before standardization so they all have the same direction (the higher, the better). According to previous methodology, the GCF was calculated as T-scores, with raw scores of a healthy comparison sample. T scores were converted to deficit scores that reflect presence and severity of cognitive impairment. Deficit scores on all tests were then "averaged" to create the GCF score.
17 secondary outcomes
Change in information processing speed
Time frame: 3 years
Change in information processing speed
Time frame: 3 years
Change in information processing speed
Time frame: 3 years
Change in motor dexterity
Time frame: 3 years
Change in working memory
Time frame: 3 years
Change in working memory
Time frame: 3 years
Change in verbal learning
Time frame: 3 years
Change in visuospatial abilities
Time frame: 3 years
Change in delayed memory
Time frame: 3 years
Change in delayed memory
Time frame: 3 years
Change in attention
Time frame: 3 years
Change in executive function
Time frame: 3 years
Change in executive function
Time frame: 3 years
Change in executive function
Time frame: 3 years
Change in executive function
Time frame: 3 years
Change in executive function
Time frame: 3 years
Change in theory of mind
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 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.
Benedicto Crespo-Facorro, Professor principal investigator
University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Santander, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole and Risperidone in people with Schizophrenia and Psychotic Disorders, run by Fundación Marques de Valdecilla 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 5 inclusion and 3 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 14 Jan 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 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive index (time frame: 3 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 14 Jan 2020.