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Trial record 41 of 1537 for:    child psychiatry

ADHD Medication and Predictors of Treatment Outcome (ADAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02136147
Recruitment Status : Enrolling by invitation
First Posted : May 12, 2014
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Linda Halldner Henriksson, Karolinska Institutet

Tracking Information
First Submitted Date April 30, 2014
First Posted Date May 12, 2014
Last Update Posted Date July 9, 2019
Study Start Date June 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2014)
  • change in SNAP-IV Teacher and Parent rating scale (Swanson, Nolan and Pelham ADHD Rating Scale) [ Time Frame: at 3 months follow-up ]
    ADHD symptoms
  • change in P-SEC (Pediatric Side Effects Checklist) [ Time Frame: at 3 months follow-up ]
    Side-effect measure
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02136147 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 5, 2019)
  • change in C-GAS (Children´s global assessment scale) [ Time Frame: at 12 months follow-up ]
    global functioning measure
  • change in CGI-S (Clinical Global Impression- of Severity) [ Time Frame: at 12 months follow-up ]
    disease severity
  • change in SNAP-IV Teacher and Parent rating scale [ Time Frame: at 1 month follow-up ]
    ADHD symptoms
  • change in SNAP-IV Teacher and Parent rating scale [ Time Frame: at 6 months follow-up ]
    ADHD symptoms
  • change in SNAP-IV Teacher and Parent rating scale [ Time Frame: at 12 months follow-up ]
    ADHD symptoms
  • change in P-SEC (Pediatric Side Effects Checklist) [ Time Frame: at 1 month follow-up ]
    side effect measure
  • change in P-SEC (Pediatric Side Effects Checklist) [ Time Frame: at 6 months follow-up ]
    side effect measure
  • change in P-SEC (Pediatric Side Effects Checklist) [ Time Frame: at 12 months follow-up ]
    side effect measure
  • change in Spence Children's Anxiety Scale (SCAS) [ Time Frame: at 1 month follow-up ]
    symptoms of anxiety
  • change in Spence Children's Anxiety Scale (SCAS) [ Time Frame: at 3 months follow-up ]
    symptoms of anxiety
  • change in Spence Children's Anxiety Scale (SCAS) [ Time Frame: at 6 months follow-up ]
    symptoms of anxiety
  • change in Spence Children's Anxiety Scale (SCAS) [ Time Frame: at 12 months follow-up ]
    symptoms of anxiety
  • change in heart rate [ Time Frame: at 1 month follow-up ]
  • change in heart rate [ Time Frame: at 3 months follow-up ]
  • change in heart rate [ Time Frame: at 6 months follow-up ]
  • change in heart rate [ Time Frame: at 12 months follow-up ]
  • change in systolic blood pressure [ Time Frame: at 1 month follow-up ]
  • change in systolic blood pressure [ Time Frame: at 3 months follow-up ]
  • change in systolic blood pressure [ Time Frame: at 6 months follow-up ]
  • change in systolic blood pressure [ Time Frame: at 12 months follow-up ]
  • change in diastolic blood pressure [ Time Frame: at 1 month follow-up ]
  • change in diastolic blood pressure [ Time Frame: at 3 months follow-up ]
  • change in diastolic blood pressure [ Time Frame: at 6 months follow-up ]
  • change in diastolic blood pressure [ Time Frame: at 12 months follow-up ]
  • change in weight z-score [ Time Frame: at 1 month follow-up ]
  • change in weight z-score [ Time Frame: at 3 months follow-up ]
  • change in weight z-score [ Time Frame: at 6 months follow-up ]
  • change in weight z-score [ Time Frame: at 12 months follow-up ]
  • change in height z-score [ Time Frame: at 6 months follow-up ]
  • change in height z-score [ Time Frame: at 12 months follow-up ]
  • change in Autism Spectrum Screening Questionnaire (ASSQ) score [ Time Frame: at 3 months follow-up ]
    symptoms of autism
  • change in Autism Spectrum Screening Questionnaire (ASSQ) score [ Time Frame: at 1 months follow-up ]
    symptoms of autism
  • change in Autism Spectrum Screening Questionnaire (ASSQ) score [ Time Frame: at 6 months follow-up ]
    symptoms of autism
  • change in Autism Spectrum Screening Questionnaire (ASSQ) score [ Time Frame: at 12 months follow-up ]
    symptoms of autism
Original Secondary Outcome Measures
 (submitted: May 8, 2014)
  • change in CGI-S (Clinical Global Impression- of Severity) [ Time Frame: at 3 month follow-up ]
    disease severity
  • change in C-GAS (Children´s global assessment scale) [ Time Frame: at 3 months follow-up ]
    global functioning measure
  • change in CGI-S (Clinical Global Impression- of Severity) [ Time Frame: at 1 month follow-up ]
    disease severity
  • change in CGI-S (Clinical Global Impression- of Severity) [ Time Frame: at 6 month follow-up ]
    disease severity
  • change in CGI-S (Clinical Global Impression- of Severity) [ Time Frame: at 12 months follow-up ]
    disease severity
  • change in SNAP-IV Teacher and Parent rating scale [ Time Frame: at 1 month follow-up ]
    ADHD symptoms
  • change in SNAP-IV Teacher and Parent rating scale [ Time Frame: at 6 months follow-up ]
    ADHD symptoms
  • change in SNAP-IV Teacher and Parent rating scale [ Time Frame: at 12 months follow-up ]
    ADHD symptoms
  • change in P-SEC (Pediatric Side Effects Checklist) [ Time Frame: at 1 month follow-up ]
    side effect measure
  • change in P-SEC (Pediatric Side Effects Checklist) [ Time Frame: at 6 months follow-up ]
    side effect measure
  • change in P-SEC (Pediatric Side Effects Checklist) [ Time Frame: at 12 months follow-up ]
    side effect measure
  • change in Spence Children's Anxiety Scale (SCAS) [ Time Frame: at 1 month follow-up ]
    symptoms of anxiety
  • change in Spence Children's Anxiety Scale (SCAS) [ Time Frame: at 3 months follow-up ]
    symptoms of anxiety
  • change in Spence Children's Anxiety Scale (SCAS) [ Time Frame: at 6 months follow-up ]
    symptoms of anxiety
  • change in Spence Children's Anxiety Scale (SCAS) [ Time Frame: at 12 months follow-up ]
    symptoms of anxiety
  • change in heart rate [ Time Frame: at 1 month follow-up ]
  • change in heart rate [ Time Frame: at 3 months follow-up ]
  • change in heart rate [ Time Frame: at 6 months follow-up ]
  • change in heart rate [ Time Frame: at 12 months follow-up ]
  • change in systolic blood pressure [ Time Frame: at 1 month follow-up ]
  • change in systolic blood pressure [ Time Frame: at 3 months follow-up ]
  • change in systolic blood pressure [ Time Frame: at 6 months follow-up ]
  • change in systolic blood pressure [ Time Frame: at 12 months follow-up ]
  • change in diastolic blood pressure [ Time Frame: at 1 month follow-up ]
  • change in diastolic blood pressure [ Time Frame: at 3 months follow-up ]
  • change in diastolic blood pressure [ Time Frame: at 6 months follow-up ]
  • change in weight z-score [ Time Frame: at 1 month follow-up ]
  • change in weight z-score [ Time Frame: at 3 months follow-up ]
  • change in weight z-score [ Time Frame: at 6 months follow-up ]
  • change in weight z-score [ Time Frame: at 12 months follow-up ]
  • change in height z-score [ Time Frame: at 6 months follow-up ]
  • change in height z-score [ Time Frame: at 12 months follow-up ]
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2014)
  • change in self-harm frequency [ Time Frame: at 12 months follow-up ]
    change in self-harm frequency behavior as noted in the quality register BUSA
  • change in suicide attempt frequency [ Time Frame: at 12 months follow-up ]
    change in suicide attempt frequency as reported in quality register BUSA
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title ADHD Medication and Predictors of Treatment Outcome
Official Title Naturalistic Study of ADHD Medication and Predictors of Treatment Outcome
Brief Summary ADHD medication of children and adolescents is becoming increasingly common. Clinical experience and scientific studies have proven that approximately 30% of children/adolescents with ADHD do not benefit from this treatment. However, there is insufficient knowledge about who these children are. All children and adolescents, who start treatment with ADHD medication at public Child and Adolescent Psychiatry units in Stockholm, on Gotland, an in Västerbotten, will be asked to participate in the study. The investigators intend to monitor the patients´clinical symptoms and possible side-effects after treatment start. The investigators will collect background information and saliva samples from the patient and his/her parents to be able to study if there are any genetic (hereditary) or other markers that can predict positive or negative outcomes of the ADHD medication. With this information, the investigators aim at, to a greater extent, be able to individualize treatment choices for children and adolescents with ADHD without unnecessary, costly and possibly unfavorable treatment attempts.
Detailed Description

The specific aims for the ADAPT study are:

  1. Investigate if certain gene polymorphisms are associated with poor effect of ADHD drugs (non-responders).
  2. Investigate if other biologically, phenotypic or psychosocial factors are associated with poor effect of ADHD drugs (non-responders).
  3. Investigate if the frequency of side-effects of ADHD drugs differs between children with different genotypes.
  4. Investigate if the frequency of side-effects of ADHD drugs differs between children with different phenotypic and/or psychosocial factors

Method:

This study has a naturalistic design. The aim is to map all new treatments with ADHD drugs at all 13 public BUP units in Stockholm County, one BUP unit on Gotland, and three BUP units in Västerbotten Region. The participation means that medication is initiated as planned in normal clinical practice by the child´s ordinary physician, and beyond this only means a somewhat denser and more structured follow-up. In addition, the investigators will ask for saliva samples from the patient and his/her parents. The investigators aim at including at least 1000 individuals in total in the study.

Part of the data will be collected via the national Quality Register for ADHD Treatment Follow-up (BUSA), which has approved security procedures approved by the Swedish Data Inspection Board.

Case report forms are computerized and separate from the database registry for collected study data. The database and detailed variable lists are constructed in collaboration with professional database managers.

Standard Operation Procedures are designed in collaboration by project coordinator, study nurse and principal investigator, and may be revised after pilot phase.

Collected samples will be stored at KI biobank.

Data analysis:

  1. To judge if the patient is a responder to ADHD drugs the SNAP-IV rating of ADHD symptoms (before and after medication start) is used. The patients who at 3 months have an at least 40% reduction in SNAP-IV score are reckoned "responders" and those who at the same time point have a less than 20% change in SNAP-IV score are reckoned "non-responders". Differences between the groups will be analyzed with logistic regression, with responder status as depending variable, and genotype and the other risk markers (biological, phenotypic, and psychosocial markers) as independent variables after correction for symptoms at baseline. Even a 50% drop-out rate will (i.e. 1000 out of estimated 2000 eligible individuals) give a 98% power to identify a 49% increase in non-responder proportion for a specific genotype.
  2. Concomitantly, the outcome in side-effects, heart rate, blood pressure, weight (z-score) and length (z-score) will be analyzed with linear regression with the same independent variables.
  3. The analyses are performed separately for each ADHD drug.
  4. There are significantly more boys than girls (about 4:1) with ADHD. Given the sex difference in prevalence it is obvious to also include sex as a covariate in our analyses of treatment outcome.
  5. Missing data will be treated according to the principles of complete case and multiple imputation.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Retention:   Samples With DNA
Description:
Saliva
Sampling Method Non-Probability Sample
Study Population All children/adolescents starting ADHD medication at the public child and adolescent psychiatry services in Stockholm and on Gotland
Condition Attention Deficit Disorder With Hyperactivity (ADHD)
Intervention
  • Drug: methylphenidate medication
    Other Names:
    • N06BA04
    • Concerta
    • Ritalin
    • Equasym
    • Medikinet
  • Drug: atomoxetine medication
    Other Names:
    • N06BA09
    • Strattera
  • Drug: lisdexamphetamine medication
    Other Names:
    • N06BA12
    • Elvanse
  • Drug: guanfacine medication
    Other Names:
    • C02AC02
    • Intuniv
Study Groups/Cohorts
  • Children with ADHD medication
    Identified responders and non-responders in children/adolescents starting medication for treatment of ADHD in public child and adolescent psychiatric services in Stockholm, on Gotland, and in Västerbotten.
    Interventions:
    • Drug: methylphenidate medication
    • Drug: atomoxetine medication
    • Drug: lisdexamphetamine medication
    • Drug: guanfacine medication
  • Lisdexamphetamine medication
    Identified responders and non-responders in children/adolescents starting medication with lisdexamphetamine in public child and adolescent psychiatric services in Stockholm and on Gotland.
    Intervention: Drug: lisdexamphetamine medication
  • Atomoxetine medication
    Identified responders and non-responders in children/adolescents starting medication with atomoxetine in public child and adolescent psychiatric services in Stockholm and on Gotland.
    Intervention: Drug: atomoxetine medication
  • Methylphenidate medication
    Identified responders and non-responders in children/adolescents starting medication with methylphenidate in public child and adolescent psychiatric services in Stockholm and on Gotland.
    Intervention: Drug: methylphenidate medication
  • Guanfacine medication
    Identified responders and non-responders in children/adolescents starting medication with guanfacine in public child and adolescent psychiatric services in Stockholm and on Gotland.
    Intervention: Drug: guanfacine medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 8, 2014)
2000
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of ADHD
  • Starting medication against ADHD symptoms with atomoxetine, methylphenidate, lisdexamphetamine, or guanfacine

Exclusion Criteria: Any medication against ADHD the last 3 months

Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02136147
Other Study ID Numbers ADAPT
LS 1110-1339 ( Other Grant/Funding Number: ALF/PPG )
SLS-309701 ( Other Grant/Funding Number: Stiftelsen Söderström-Königska sjukhemmet )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Linda Halldner Henriksson, Karolinska Institutet
Study Sponsor Karolinska Institutet
Collaborators Not Provided
Investigators Not Provided
PRS Account Karolinska Institutet
Verification Date July 2019