SchizophreniaEarly Phase 1NCT01788436
A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers
A Early Phase 1 study testing Cognitive Test Battery 1 and Cognitive Test Battery 2 in people with Schizophrenia, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive Test Battery 1 and Cognitive Test Battery 2
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2012to May 2014
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1 (patients with schizophrenia):
- Be a man or woman between 18 and 55 years of age, inclusive
- Has a known history of schizophrenia of at least 12 months by the referring psychiatrist
- Receives stable antipsychotic drug therapy (maximally 2) for at least 6 weeks prior to screening
- Medically stable on the basis of clinical judgment by the investigator
- Group 2 (young healthy volunteers): be a healthy man or woman between 18 and 55 years of age, inclusive
- Group 3 (elderly healthy volunteers): be a healthy man or woman between 65 and 85 years of age, inclusive
- All participants (Group 1 to 3) must be capable of completing the cognitive test battery
Who cannot join
- Receives treatment with benzodiazepines, tricyclic antidepressant or anticholinergics
- Has a positive urine screen for drugs of abuse or alcohol breath test
- Has a recent history (within previous 6 months) of alcohol or drug abuse
- Has psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the participant to comply with the study requirements
- Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the participant or the study or prevent the participant from meeting or performing study requirements
- Group 1 only: a diagnosis of substance dependence within 3 months prior to screening evaluation (patient with a positive drug screen at screening may be included provided use does not lead to a diagnosis of substance dependence and patient consents to abstain from illegal drugs at any time during the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study to Measure and Contrast Implicit and Explicit Learning Performance in Patients With Stable Schizophrenia and Young and Elderly Healthy Subjects
The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers.
Read the detailed description
This is an exploratory study involving schizophrenic patients (Group 1) and young and elderly healthy volunteers (Group 2 and 3 respectively). No investigational medicinal product will be administered. For all participants enrolled (Group 1 to 3) the study will consist of an eligibility screening examination (from Day -21 up to and including Day 1) and 3 cognitive assessment days. Cognitive assessments will be made on 2 subsequent days (Days 1 and 2) which are separated by overnight sleep. In addition, a session will be performed on Day 7. Completion of the cognitive test batteries can occur at any time during the day provided that the completion time is comparable on all test days. For each participant, the maximal study duration will not exceed 4 weeks.
- Conditions
- Schizophrenia
- Being tested
- Cognitive Test Battery 1, Cognitive Test Battery 2
- Keywords
- Schizophrenia, Young healthy volunteers, Elderly healthy volunteers, Learning performance
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Test Battery 1Behavioural
The Cognitive Test Battery 1 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Pattern/Sequence Learning Task (PLT_Impl); Verbal Learning Test (VLT); Figure drawing; Mirror Drawing; Explicit Pattern Learning Task (PLT_Expl); Delayed Recall and Recognition Test; and Pursuit rotor.
Cognitive Test Battery 2Behavioural
The Cognitive Test Battery 2 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Learning Retention Test; Hopkins Verbal Learning Test (HVLT); Figure drawing; Mirror Drawing; Explicit Learning Retention Test; Instrumental Learning Task; Pursuit rotor; and Sensory Motor Interception Adaptation Task.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients with schizophrenia | Experimental | Not described Receives: Behavioral: Cognitive Test Battery 1; Behavioral: Cognitive Test Battery 2 |
| Group 2: Young healthy volunteers | Active comparator | Not described Receives: Behavioral: Cognitive Test Battery 1; Behavioral: Cognitive Test Battery 2 |
| Group 3: Elderly healthy volunteers | Experimental | Not described Receives: Behavioral: Cognitive Test Battery 1; Behavioral: Cognitive Test Battery 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of implicit and explicit learning through cognitive testing over a period of 7 days
The cognitive data will be summarized and summary statistics calculated (including mean, standard deviation, median, minimum, and maximum values) for each experiment and participants group.
Measured: 7 days
Secondary outcomes (1)
Incidence of Adverse Events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788436
- Sponsor's protocol ID
- CR100911
- Other IDs
- NOCOMPOUNDEDI0004
- Status last verified
- Jun 2014
- First submitted
- 8 Nov 2012
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Measure and Contrast Implicit and Explicit Learning Performance in Patients With Stable Schizophrenia and Young and Elderly Healthy Subjects
- ClinicalTrials.gov ID
- NCT01788436
- Acronym / sponsor ID
- CR100911
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Young healthy volunteers, Elderly healthy volunteers, Learning performance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Feb 2013 (estimated)
- 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.
The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers.
Detailed description
This is an exploratory study involving schizophrenic patients (Group 1) and young and elderly healthy volunteers (Group 2 and 3 respectively). No investigational medicinal product will be administered. For all participants enrolled (Group 1 to 3) the study will consist of an eligibility screening examination (from Day -21 up to and including Day 1) and 3 cognitive assessment days. Cognitive assessments will be made on 2 subsequent days (Days 1 and 2) which are separated by overnight sleep. In addition, a session will be performed on Day 7. Completion of the cognitive test batteries can occur at any time during the day provided that the completion time is comparable on all test days. For each participant, the maximal study duration will not exceed 4 weeks.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients with schizophrenia | Experimental | Behavioral: Cognitive Test Battery 1, Behavioral: Cognitive Test Battery 2 |
| Group 2: Young healthy volunteers | Active comparator | Behavioral: Cognitive Test Battery 1, Behavioral: Cognitive Test Battery 2 |
| Group 3: Elderly healthy volunteers | Experimental | Behavioral: Cognitive Test Battery 1, Behavioral: Cognitive Test Battery 2 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Group 1 (patients with schizophrenia):
- Be a man or woman between 18 and 55 years of age, inclusive
- Has a known history of schizophrenia of at least 12 months by the referring psychiatrist
- Receives stable antipsychotic drug therapy (maximally 2) for at least 6 weeks prior to screening
- Medically stable on the basis of clinical judgment by the investigator
Key exclusion criteria (6 listed)
- Receives treatment with benzodiazepines, tricyclic antidepressant or anticholinergics
- Has a positive urine screen for drugs of abuse or alcohol breath test
- Has a recent history (within previous 6 months) of alcohol or drug abuse
- Has psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the participant to comply with the study requirements
- Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the participant or the study or prevent the participant from meeting or performing study requirements
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 |
|---|---|---|
| Cognitive Test Battery 1The Cognitive Test Battery 1 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Pattern/Sequence Learning Task (PLT_Impl); Verbal Learning Test (VLT); Figure drawing; Mirror Drawing; Explicit Pattern Learning Task (PLT_Expl); Delayed Recall and Recognition Test; and Pursuit rotor. | Behavioural | Group 1: Patients with schizophrenia, Group 2: Young healthy volunteers, Group 3: Elderly healthy volunteers |
| Cognitive Test Battery 2The Cognitive Test Battery 2 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Learning Retention Test; Hopkins Verbal Learning Test (HVLT); Figure drawing; Mirror Drawing; Explicit Learning Retention Test; Instrumental Learning Task; Pursuit rotor; and Sensory Motor Interception Adaptation Task. | Behavioural | Group 1: Patients with schizophrenia, Group 2: Young healthy volunteers, Group 3: Elderly healthy volunteers |
Primary outcome
Measurement of implicit and explicit learning through cognitive testing over a period of 7 days
Time frame: 7 days
The cognitive data will be summarized and summary statistics calculated (including mean, standard deviation, median, minimum, and maximum values) for each experiment and participants group.
1 secondary outcome
Incidence of Adverse Events
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Cognitive Test Battery 1 and Cognitive Test Battery 2 in people with Schizophrenia, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 17 Jun 2014. 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 Belgium. 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?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of implicit and explicit learning through cognitive testing over a period of 7 days (time frame: 7 days). 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 17 Jun 2014.