ADHDNCT02906501
Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances
An observational study of ADHD, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
Introduction: The use of low dose risperidone and other antipsychotic drugs off-label as augmentation treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD) and Disruptive Behavioral Disorder (DBD) has become widely common worldwide, usually to help control behavioral difficulties. Read more about this study
- Who is it for?
- Ages 8 to 17 years, men only
- Conditions the study is for
- ADHD
- What is being tested?
- The Penn Web-Based Computerized Neurocognitive Battery and The Iowa Gambling Test (IGT)
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Mar 2018
- Phase
- Observational
- 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 8 to 17 years
- Men only
- No healthy volunteers
- Child
Study population: Children and adolescents diagnosed with ADHD, 8-17 years old, may be eligible for this study. Informed consent will be obtained from potential subjects' parents, and subjects will provide their own assent, according to the local and national IRB committees.
Who may be able to join
- Male children and adolescents diagnosed with ADHD Age: 8-17 years.
- Psychiatric comorbidities including: Major Depressive disorder, General Anxiety Disorder, Panic Disorder, Obsessive Compulsive Disorder, Oppositional Defiant Disorder, Conduct Disorder, Disruptive Dysregulation Mood Disorder, Intermittent Explosive Disorder and all phobias.
Who cannot join
- Any current serious medical or surgical illness.
- History of a major neurological illnesses (including brain injury).
- Psychiatric comorbidities including: All psychotic disorders, Bipolar Disorder and personality disorders.
- History of alcohol or substance abuse.
- Intellectual disability: Total IQ< 70
Trial locations and contacts
1 site in 1 country.
Israel1 site
Cognition Research Lab Shalvata Mental Hspital
Hod HaSharon
CHEN DROR, M.D, +9729-7478644, chendr1@clalit.org.il
Yuval BlOCH, M.D, +9729-7478644, yuvalbl@clalit.org.il
About this study
Official title: Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral
Introduction: The use of low dose risperidone and other antipsychotic drugs off-label as augmentation treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD) and Disruptive Behavioral Disorder (DBD) has become widely common worldwide, usually to help control behavioral difficulties. While some argue that agents that block dopaminergic receptors may have a deleterious cognitive effect, others stress their moderating effects, which possibly improve function in all domains, including cognitive functions. Only a few studies have examined this topic, with inconclusive results.
Aim of study: To measure the effect of risperidone treatment on various cognitive functions in a population of ADHD diagnosed children and adolescents with normal IQ.
Read more
Design: The study is an observational prospective open label clinical controlled trial. The investigators will compare the performance in a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP) and the IGT, in children and adolescents diagnosed with ADHD, with and without risperidone.
Study population: Children and adolescents diagnosed with ADHD, 8-17 years old, may be eligible for this study. We will recruit subjects who their psychiatrist is considering rispieridone treatment, those who are already treated with risperidone and subjects with only stimulants treatment. All pharmacological treatment is supervised and prescribed to subjects by their personal psychiatrist unrelated to the study.
Significance: Better knowledge of the specific cognitive effects of this form of therapy will help us guide both clinical decisions, and recommended monitoring in daily clinical work.
Read the detailed description
Study Purpose: To evaluate the effect of atypical antipsychotic augmentation, specifically risperidone on specific cognitive domains in adolescents with ADHD and behavioral disturbances.
Hypotheses:
- Risperidone will improve performance in tasks assessing attention, verbal memory, visual memory and working memory in adolescents with ADHD and DBDs
- Risperidone will impair performance in tasks assessing spatial memory and some executive functions in adolescents with ADHD and DBDs.
- Risperidone, but not other atypical antipsychotic, will improve performance on the IGT.
Study Design
General:
This study is an observational prospective open label clinical controlled trial.
The planned study will compare performance, with and without the effect of risperidone, in various cognitive tasks in children and adolescents diagnosed with ADHD.
Each subject will perform a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP) and the Iowa Gambling Test (IGT).
Experimental Procedure
Each potential subject and his parents will be screened on the phone for the study. All enrolled subjects will be instructed to avoid taking any stimulant treatment on the days of assessment sessions. On the day of enrolment, each subject will be evaluated by a standard basic medical interview and physical and neurological examinations for evidence of current neurological and physical disorders. They will also be evaluated by the Development and Well-Being Assessment (DAWBA) for evidence of any psychiatric disorders. Parents will also answer DAWBA questionnaire. Subjects who will qualify for the study and their parents will receive a comprehensive explanation on the study and will sign an informed consent form. Subjects will then complete The Penn Web-Based Computerized Neurocognitive Battery (WebCNP) and the Iowa Gambling Test (IGT). The first session will take approximately 2.5 hours. All subjects will undergo a follow up session approximately a month after the first session. The second session will take approximately 2 hours. Subjects in Groups II will be instructed to start taking their risperidone after the first session and on the day of the follow up session. Subjects on Group III will be instructed to take their risperidone or other atypical antipsychotic treatment on days of the experiment in the night before the session at least 8 hours before the sessions and in the month between them. The treatments with Risperidone will be given only according to the decision and guidance of the subject's physician. All subjects will be invited to perform the Penn Continuous Performance Test for a third time, under the influence of their stimulant treatment. Normal IQ will be ascertained using the Raven's Progressive Matrices task which is a part of the WebCNP battery.
- Conditions
- ADHD
- Being tested
- The Penn Web-Based Computerized Neurocognitive Battery, The Iowa Gambling Test (IGT)
- Keywords
- Risperidone, ADHD, DBD, IGT, CNP, Executive functions
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Penn Web-Based Computerized Neurocognitive BatteryProcedure or surgery
The Battery (PennCNP) of the Brain Behavior Laboratory at the University of Pennsylvania offers a range of probes of human neuropsychological functioning . It was designed for neuropsychological measurement of major cognitive domains. The WebCNP is administered using clickable icons on desktop or laptop computers, in a fixed order. Administrating the tests in a standard fashion fostering optimal performance without aiding the participant is required. For each domain, accuracy and speed are computed. Full battery completion takes approximately 2 hours. Each test begins with a practice module, to assure understanding of the instructions.
The Iowa Gambling Test (IGT)Procedure or surgery
The essential feature of this task is that it mimics real-life situations in the way it factors uncertainty, reward and punishment. The task involves four decks of cards, named A, B, C and D. The goal is to maximize profit on a loan of play money. Subjects are required to make a series of 100 card selections, but are not told ahead of time how many card selections they are going to be allowed to make. Cards can be selected one at a time, from any deck, and subjects are free to switch from any deck to another, at any time and as often as they wish. The decision to select from one deck or another is largely influenced by schedules of reward and punishment. These schedules are pre-programmed and known to the examiner, but not to the subject (Bechara et al., 1994, 1999a).
| Study group | Role | What they receive |
|---|---|---|
| Group I (n=15) | Male children and adolescents diagnosed with ADHD not treated with risperidone or any other antipsychotic treatment. Receives: Procedure: The Penn Web-Based Computerized Neurocognitive Battery; Procedure: The Iowa Gambling Test (IGT) | |
| Group II (n=15) | Male children and adolescents diagnosed with ADHD intended to start risperidone or any other antipsychotic treatment due to behavioral problems. Receives: Procedure: The Penn Web-Based Computerized Neurocognitive Battery; Procedure: The Iowa Gambling Test (IGT) | |
| Group III (n=15) | Male children and adolescents diagnosed with ADHD treated with risperidone or any other antipsychotic treatment due to behavioral problems. Receives: Procedure: The Penn Web-Based Computerized Neurocognitive Battery; Procedure: The Iowa Gambling Test (IGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Penn Web-Based Computerized Neurocognitive Battery (WebCNP) scores
Measured: 1 year
Secondary outcomes (1)
Iowa Gambling Task (IGT) scores
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziv Carmel, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906501
- Sponsor's protocol ID
- SHA-000-7-16
- Status last verified
- Sep 2016
- First submitted
- 11 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral
- ClinicalTrials.gov ID
- NCT02906501
- Acronym / sponsor ID
- SHA-000-7-16
- Conditions
- ADHD
- Keywords
- Risperidone, ADHD, DBD, IGT, CNP, Executive functions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 20 Sep 2016 (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.
Introduction: The use of low dose risperidone and other antipsychotic drugs off-label as augmentation treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD) and Disruptive Behavioral Disorder (DBD) has become widely common worldwide, usually to help control behavioral difficulties. While some argue that agents that block dopaminergic receptors may have a deleterious cognitive effect, others stress their moderating effects, which possibly improve function in all domains, including cognitive functions. Only a few studies have examined this topic, with inconclusive results.
Aim of study: To measure the effect of risperidone treatment on various cognitive functions in a population of ADHD diagnosed children and adolescents with normal IQ.
Design: The study is an observational prospective open label clinical controlled trial. The investigators will compare the performance in a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP) and the IGT, in children and adolescents diagnosed with ADHD, with and without risperidone.
Study population: Children and adolescents diagnosed with ADHD, 8-17 years old, may be eligible for this study. We will recruit subjects who their psychiatrist is considering rispieridone treatment, those who are already treated with risperidone and subjects with only stimulants treatment. All pharmacological treatment is supervised and prescribed to subjects by their personal psychiatrist unrelated to the study.
Significance: Better knowledge of the specific cognitive effects of this form of therapy will help us guide both clinical decisions, and recommended monitoring in daily clinical work.
Detailed description
Study Purpose: To evaluate the effect of atypical antipsychotic augmentation, specifically risperidone on specific cognitive domains in adolescents with ADHD and behavioral disturbances.
Hypotheses:
- Risperidone will improve performance in tasks assessing attention, verbal memory, visual memory and working memory in adolescents with ADHD and DBDs
- Risperidone will impair performance in tasks assessing spatial memory and some executive functions in adolescents with ADHD and DBDs.
- Risperidone, but not other atypical antipsychotic, will improve performance on the IGT.
Study Design
General:
This study is an observational prospective open label clinical controlled trial.
The planned study will compare performance, with and without the effect of risperidone, in various cognitive tasks in children and adolescents diagnosed with ADHD.
Each subject will perform a battery of cognitive tasks using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP) and the Iowa Gambling Test (IGT).
Experimental Procedure
Each potential subject and his parents will be screened on the phone for the study. All enrolled subjects will be instructed to avoid taking any stimulant treatment on the days of assessment sessions. On the day of enrolment, each subject will be evaluated by a standard basic medical interview and physical and neurological examinations for evidence of current neurological and physical disorders. They will also be evaluated by the Development and Well-Being Assessment (DAWBA) for evidence of any psychiatric disorders. Parents will also answer DAWBA questionnaire. Subjects who will qualify for the study and their parents will receive a comprehensive explanation on the study and will sign an informed consent form. Subjects will then complete The Penn Web-Based Computerized Neurocognitive Battery (WebCNP) and the Iowa Gambling Test (IGT). The first session will take approximately 2.5 hours. All subjects will undergo a follow up session approximately a month after the first session. The second session will take approximately 2 hours. Subjects in Groups II will be instructed to start taking their risperidone after the first session and on the day of the follow up session. Subjects on Group III will be instructed to take their risperidone or other atypical antipsychotic treatment on days of the experiment in the night before the session at least 8 hours before the sessions and in the month between them. The treatments with Risperidone will be given only according to the decision and guidance of the subject's physician. All subjects will be invited to perform the Penn Continuous Performance Test for a third time, under the influence of their stimulant treatment. Normal IQ will be ascertained using the Raven's Progressive Matrices task which is a part of the WebCNP battery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (n=15) | – | Procedure: The Penn Web-Based Computerized Neurocognitive Battery, Procedure: The Iowa Gambling Test (IGT)Male children and adolescents diagnosed with ADHD not treated with risperidone or any other antipsychotic treatment. |
| Group II (n=15) | – | Procedure: The Penn Web-Based Computerized Neurocognitive Battery, Procedure: The Iowa Gambling Test (IGT)Male children and adolescents diagnosed with ADHD intended to start risperidone or any other antipsychotic treatment due to behavioral problems. |
| Group III (n=15) | – | Procedure: The Penn Web-Based Computerized Neurocognitive Battery, Procedure: The Iowa Gambling Test (IGT)Male children and adolescents diagnosed with ADHD treated with risperidone or any other antipsychotic treatment due to behavioral problems. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents diagnosed with ADHD, 8-17 years old, may be eligible for this study. Informed consent will be obtained from potential subjects' parents, and subjects will provide their own assent, according to the local and national IRB committees.
Key inclusion criteria (2 listed)
- Male children and adolescents diagnosed with ADHD Age: 8-17 years.
- Psychiatric comorbidities including: Major Depressive disorder, General Anxiety Disorder, Panic Disorder, Obsessive Compulsive Disorder, Oppositional Defiant Disorder, Conduct Disorder, Disruptive Dysregulation Mood Disorder, Intermittent Explosive Disorder and all phobias.
Key exclusion criteria (5 listed)
- Any current serious medical or surgical illness.
- History of a major neurological illnesses (including brain injury).
- Psychiatric comorbidities including: All psychotic disorders, Bipolar Disorder and personality disorders.
- History of alcohol or substance abuse.
- Intellectual disability: Total IQ< 70
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 |
|---|---|---|
| The Penn Web-Based Computerized Neurocognitive BatteryThe Battery (PennCNP) of the Brain Behavior Laboratory at the University of Pennsylvania offers a range of probes of human neuropsychological functioning . It was designed for neuropsychological measurement of major cognitive domains. The WebCNP is administered using clickable icons on desktop or laptop computers, in a fixed order. Administrating the tests in a standard fashion fostering optimal performance without aiding the participant is required. For each domain, accuracy and speed are computed. Full battery completion takes approximately 2 hours. Each test begins with a practice module, to assure understanding of the instructions. | Procedure or surgery | Group I (n=15), Group II (n=15), Group III (n=15) |
| The Iowa Gambling Test (IGT)The essential feature of this task is that it mimics real-life situations in the way it factors uncertainty, reward and punishment. The task involves four decks of cards, named A, B, C and D. The goal is to maximize profit on a loan of play money. Subjects are required to make a series of 100 card selections, but are not told ahead of time how many card selections they are going to be allowed to make. Cards can be selected one at a time, from any deck, and subjects are free to switch from any deck to another, at any time and as often as they wish. The decision to select from one deck or another is largely influenced by schedules of reward and punishment. These schedules are pre-programmed and known to the examiner, but not to the subject (Bechara et al., 1994, 1999a). | Procedure or surgery | Group I (n=15), Group II (n=15), Group III (n=15) |
Primary outcome
The Penn Web-Based Computerized Neurocognitive Battery (WebCNP) scores
Time frame: 1 year
1 secondary outcome
Iowa Gambling Task (IGT) scores
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Shalvata Mental Health Center at 1 site in Israel.
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 2 inclusion and 5 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 20 Sep 2016. 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 Israel. 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.
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 CHEN DROR, M.D (+9729-7478644, chendr1@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Penn Web-Based Computerized Neurocognitive Battery (WebCNP) scores (time frame: 1 year). 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 20 Sep 2016.