Attention Deficit Disorder With HyperactivityPhase 4LMANCT03250013
Long-term Effects of Medication for ADHD
A Phase 4 study testing ADHD medications in people with Attention Deficit Disorder With Hyperactivity, run by Göteborg University at 1 site in Sweden.
Trial summary
Single-centre open-label prospective study, enrolling 127 children and adolescents aged 6-17 years, who receive medication for ADHD of any subtype (presentation). Long-term results are evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales; WISC), adaptive functioning (Vineland scale)… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- ADHD medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to 30 Jan 2022
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6-17 years of age
- Clinical diagnosis ADHD of any subtype and DSM 5 presentation
- Intellectual ability in the normal range, according to Wechsler tests and clinical judgment
- Subjects treated with ADHD medication will have a wash-out period prior to Qb-test at baseline, of 1 week for methylphenidate or amphetamine, 2 weeks for atomoxetine
Who cannot join
- Physical or psychological limitation making Qb-test unsuitable.
- Cardiovascular disease, seizures or other unstable medical conditions that might increase the risk for the subject.
- Bipolar Disorder, Conduct Disorder, Psychosis, severe autism or other severe comorbid or medical conditions that in the investigator's opinion would make study participation unsuitable.
- Concomitant medications (allowed at investigator's discretion), must be recorded in the subject's medical records and the CRF.
- Substance use.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Child Neuropsychiatry Unit, Sahlgrenska University Hospital
Gothenburg, 41118
About this study
Official title: Long-term Effects of Medication for Attention Deficit Hyperactivity Disorder (ADHD) in Children and Adolescents on Cognition, Everyday Function and Quality of Life
Single-centre open-label prospective study, enrolling 127 children and adolescents aged 6-17 years, who receive medication for ADHD of any subtype (presentation). Long-term results are evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales; WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional Impairment Scale; WFIRS), and quality of life (Child Health and Illness Profile-Child Edition Scale; CHIP-CE) during 24 months of ADHD treatment.
Read the detailed description
Single-centre open-label prospective study, including 127 subjects over a period of 2 years. Children and adolescents (6-17 years) who have been diagnosed with ADHD will be enrolled and followed during 24 months of ADHD treatment.
Screening assessments include medical, neurodevelopmental and psychiatric history, clinical evaluation and definition of the ADHD diagnosis and its subtypes or presentations (according to Diagnostic and Statistical Manual (DSM) IV and DSM 5), ADHD symptom severity and global functional impairment (by the investigator-rated ADHD Rating Scale-IV (ADHD-RS-IV) and Clinical Global Impression Scale-Severity and Improvement; CGI-S and CGI-I), comorbidities (by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinical interview), intellectual ability (by the WISC test), and general level of functioning (by the Vineland interview). Subjects previously assessed and diagnosed will be re-assessed at the screening visit to ascertain a current evaluation and definition of these parameters.
At baseline, a Qb-test and an assessment of symptom severity and global functional impairment will be made by the investigator-rated ADHD-RS-IV and CGI-S, everyday functioning by parent-rated WIFRS, and quality of life by parent-rated CHIP-CE. An adverse events report will be collected by interview with open-ended questions. Assignment to treatment will be individualized according to clinical picture and patient preference.
At subsequent visits (1, 2, 3, 6, 12, 18 and 24 months) the following assessments will be performed: Investigator-rated ADHD-RS-IV, CGI-S, Clinical Global Impression-Improvement (CGI-I) scales for symptom severity, global functional impairment and improvement. Adverse event report. Compliance assessment through pill count. Assessment of comorbidity status according to DSM-IV and DSM 5 checklist/interview.
A Qb-test will be performed at the 1 and 12 month visits. Everyday functioning and quality of life will be assessed by parent-rated WIFRS and CHIP-CE scales at the 12 and 24 month visits.
Duration of study treatment per subject is 24 months. Medication dosage is 1-3 doses daily as needed to optimize symptom control. Medications (methylphenidate, amphetamine, atomoxetine) will be provided by the pharmacy according to routines in standard clinical treatment.
For cluster analysis of Qb-test results, retrospective data from at least 50 patients previously diagnosed at our clinic will be added to the data from the subjects participating in the prospective study, to increase sample size to ascertain sufficient power for subgroup (cluster) analysis.
Safety evaluations Adverse event (AE) reports will be collected at all visits through open-ended questions. Vital signs (height, weight, blood pressure, pulse) will be assessed at all visits. AE severity should be graded: Mild, Moderate or Severe, and all AEs must be followed until an outcome is known, ensuring the subject's safety. All AEs will be recorded in the subject's medical records and in the Clinical Report Form (CRF), and also reported to the Medical Products Agency according to local regulations.
Study population Approximately 100 subjects from our centre will be enrolled in the prospective study.
Retrospective data for the cluster analysis will be collected from at least 50 patients previously diagnosed at our centre.
- Being tested
- ADHD medications
- 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.
ADHD medicationsDrug
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents with ADHD | Experimental | Children and adolescents medicating for ADHD of any subtype (presentation) with comorbidities Receives: Drug: ADHD medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CGI - (S and I)
Investigator-rated clinical global impression scale - severity and improvement
Measured: 0, 1, 2, 3, 6, 12, 18 and 24 months
Secondary outcomes (6)
ADHD Rating Scale
Clinician-rated ADHD symptom scale
Measured: 0, 1, 2, 3, 6, 12, 18 and 24 months
Qb-test
Computerized ADHD-test
Measured: 0, 1 and 12 months
WISC-IV
Wechsler Intelligence Scale for Children
Measured: 0 and 12 months
Vineland scale
Vineland parent interview of functioning
Measured: 0 and 12 months
Weiss Functional Impairment Scale (WFIRS)
Parent-rated function scale
Measured: 0, 12 and 24 months
Child Health and Illness Profile - Child Edition (CHIP-CE)
Parent-rated quality of life scale
Measured: 0, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study startApr 2014
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mats Johnson, MD, PhD, Principal investigator, Child Neuropsychiatry Unit, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250013
- Sponsor's protocol ID
- LMA trial Goteborg
- Acronym
- LMA
- Status last verified
- Feb 2022
- First submitted
- 4 Aug 2017
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Medication for Attention Deficit Hyperactivity Disorder (ADHD) in Children and Adolescents on Cognition, Everyday Function and Quality of Life
- ClinicalTrials.gov ID
- NCT03250013
- Acronym / sponsor ID
- LMA / LMA trial Goteborg
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 15 Aug 2017 (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.
Single-centre open-label prospective study, enrolling 127 children and adolescents aged 6-17 years, who receive medication for ADHD of any subtype (presentation). Long-term results are evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales; WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional Impairment Scale; WFIRS), and quality of life (Child Health and Illness Profile-Child Edition Scale; CHIP-CE) during 24 months of ADHD treatment.
Detailed description
Single-centre open-label prospective study, including 127 subjects over a period of 2 years. Children and adolescents (6-17 years) who have been diagnosed with ADHD will be enrolled and followed during 24 months of ADHD treatment.
Screening assessments include medical, neurodevelopmental and psychiatric history, clinical evaluation and definition of the ADHD diagnosis and its subtypes or presentations (according to Diagnostic and Statistical Manual (DSM) IV and DSM 5), ADHD symptom severity and global functional impairment (by the investigator-rated ADHD Rating Scale-IV (ADHD-RS-IV) and Clinical Global Impression Scale-Severity and Improvement; CGI-S and CGI-I), comorbidities (by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinical interview), intellectual ability (by the WISC test), and general level of functioning (by the Vineland interview). Subjects previously assessed and diagnosed will be re-assessed at the screening visit to ascertain a current evaluation and definition of these parameters.
At baseline, a Qb-test and an assessment of symptom severity and global functional impairment will be made by the investigator-rated ADHD-RS-IV and CGI-S, everyday functioning by parent-rated WIFRS, and quality of life by parent-rated CHIP-CE. An adverse events report will be collected by interview with open-ended questions. Assignment to treatment will be individualized according to clinical picture and patient preference.
At subsequent visits (1, 2, 3, 6, 12, 18 and 24 months) the following assessments will be performed: Investigator-rated ADHD-RS-IV, CGI-S, Clinical Global Impression-Improvement (CGI-I) scales for symptom severity, global functional impairment and improvement. Adverse event report. Compliance assessment through pill count. Assessment of comorbidity status according to DSM-IV and DSM 5 checklist/interview.
A Qb-test will be performed at the 1 and 12 month visits. Everyday functioning and quality of life will be assessed by parent-rated WIFRS and CHIP-CE scales at the 12 and 24 month visits.
Duration of study treatment per subject is 24 months. Medication dosage is 1-3 doses daily as needed to optimize symptom control. Medications (methylphenidate, amphetamine, atomoxetine) will be provided by the pharmacy according to routines in standard clinical treatment.
For cluster analysis of Qb-test results, retrospective data from at least 50 patients previously diagnosed at our clinic will be added to the data from the subjects participating in the prospective study, to increase sample size to ascertain sufficient power for subgroup (cluster) analysis.
Safety evaluations Adverse event (AE) reports will be collected at all visits through open-ended questions. Vital signs (height, weight, blood pressure, pulse) will be assessed at all visits. AE severity should be graded: Mild, Moderate or Severe, and all AEs must be followed until an outcome is known, ensuring the subject's safety. All AEs will be recorded in the subject's medical records and in the Clinical Report Form (CRF), and also reported to the Medical Products Agency according to local regulations.
Study population Approximately 100 subjects from our centre will be enrolled in the prospective study.
Retrospective data for the cluster analysis will be collected from at least 50 patients previously diagnosed at our centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents with ADHD | Experimental | Drug: ADHD medicationsChildren and adolescents medicating for ADHD of any subtype (presentation) with comorbidities |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 6-17 years of age
- Clinical diagnosis ADHD of any subtype and DSM 5 presentation
- Intellectual ability in the normal range, according to Wechsler tests and clinical judgment
- Subjects treated with ADHD medication will have a wash-out period prior to Qb-test at baseline, of 1 week for methylphenidate or amphetamine, 2 weeks for atomoxetine
Key exclusion criteria (5 listed)
- Physical or psychological limitation making Qb-test unsuitable.
- Cardiovascular disease, seizures or other unstable medical conditions that might increase the risk for the subject.
- Bipolar Disorder, Conduct Disorder, Psychosis, severe autism or other severe comorbid or medical conditions that in the investigator's opinion would make study participation unsuitable.
- Concomitant medications (allowed at investigator's discretion), must be recorded in the subject's medical records and the CRF.
- Substance use.
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 |
|---|---|---|
| ADHD medications | Drug | Children and adolescents with ADHD |
Primary outcome
Change in CGI - (S and I)
Time frame: 0, 1, 2, 3, 6, 12, 18 and 24 months
Investigator-rated clinical global impression scale - severity and improvement
6 secondary outcomes
ADHD Rating Scale
Time frame: 0, 1, 2, 3, 6, 12, 18 and 24 months
Qb-test
Time frame: 0, 1 and 12 months
WISC-IV
Time frame: 0 and 12 months
Vineland scale
Time frame: 0 and 12 months
Weiss Functional Impairment Scale (WFIRS)
Time frame: 0, 12 and 24 months
Child Health and Illness Profile - Child Edition (CHIP-CE)
Time frame: 0, 12 and 24 months
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 14 Mar 2022.
- 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.
Mats Johnson, MD, PhD principal investigator
Child Neuropsychiatry Unit, Sahlgrenska University Hospital, Gothenburg, Sweden
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 ADHD medications in people with Attention Deficit Disorder With Hyperactivity, run by Göteborg University at 1 site in Sweden.
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 4 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: finished, as of the sponsor's last update on 14 Mar 2022. 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 Sweden. 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?
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?
Change in CGI - (S and I) (time frame: 0, 1, 2, 3, 6, 12, 18 and 24 months). 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 Mar 2022.