ADHD Medication and Predictors of Treatment Outcome

Attention Deficit Disorder With Hyperactivity (ADHD) Clinical Trial

— ADAPT  

Official title:

Naturalistic Study of ADHD Medication and Predictors of Treatment Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136147
• Other study ID #: ADAPT
• Secondary ID: LS 1110-1339SLS-
• Status: Completed
• Start date: June 2015
• Est. completion date: June 2022

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: June 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Disorder With Hyperactivity (ADHD)
• Hyperkinesis

Intervention

Drug:
• methylphenidate medication

• atomoxetine medication

• lisdexamphetamine medication

• guanfacine medication

Locations

Country	Name	City	State
Sweden	Division for Child and Adolescent Psychiatry in Stockholm	Stockholm	Stockholm County

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in self-harm frequency	change in self-harm frequency behavior as noted in the quality register BUSA	at 12 months follow-up
Other	change in suicide attempt frequency	change in suicide attempt frequency as reported in quality register BUSA	at 12 months follow-up
Primary	change in SNAP-IV Teacher and Parent rating scale (Swanson, Nolan and Pelham ADHD Rating Scale)	ADHD symptoms	at 3 months follow-up
Primary	change in P-SEC (Pediatric Side Effects Checklist)	Side-effect measure	at 3 months follow-up
Secondary	change in C-GAS (Children´s global assessment scale)	global functioning measure	at 12 months follow-up
Secondary	change in CGI-S (Clinical Global Impression- of Severity)	disease severity	at 12 months follow-up
Secondary	change in SNAP-IV Teacher and Parent rating scale	ADHD symptoms	at 1 month follow-up
Secondary	change in SNAP-IV Teacher and Parent rating scale	ADHD symptoms	at 6 months follow-up
Secondary	change in SNAP-IV Teacher and Parent rating scale	ADHD symptoms	at 12 months follow-up
Secondary	change in P-SEC (Pediatric Side Effects Checklist)	side effect measure	at 1 month follow-up
Secondary	change in P-SEC (Pediatric Side Effects Checklist)	side effect measure	at 6 months follow-up
Secondary	change in P-SEC (Pediatric Side Effects Checklist)	side effect measure	at 12 months follow-up
Secondary	change in Spence Children's Anxiety Scale (SCAS)	symptoms of anxiety	at 1 month follow-up
Secondary	change in Spence Children's Anxiety Scale (SCAS)	symptoms of anxiety	at 3 months follow-up
Secondary	change in Spence Children's Anxiety Scale (SCAS)	symptoms of anxiety	at 6 months follow-up
Secondary	change in Spence Children's Anxiety Scale (SCAS)	symptoms of anxiety	at 12 months follow-up
Secondary	change in heart rate		at 1 month follow-up
Secondary	change in heart rate		at 3 months follow-up
Secondary	change in heart rate		at 6 months follow-up
Secondary	change in heart rate		at 12 months follow-up
Secondary	change in systolic blood pressure		at 1 month follow-up
Secondary	change in systolic blood pressure		at 3 months follow-up
Secondary	change in systolic blood pressure		at 6 months follow-up
Secondary	change in systolic blood pressure		at 12 months follow-up
Secondary	change in diastolic blood pressure		at 1 month follow-up
Secondary	change in diastolic blood pressure		at 3 months follow-up
Secondary	change in diastolic blood pressure		at 6 months follow-up
Secondary	change in diastolic blood pressure		at 12 months follow-up
Secondary	change in weight z-score		at 1 month follow-up
Secondary	change in weight z-score		at 3 months follow-up
Secondary	change in weight z-score		at 6 months follow-up
Secondary	change in weight z-score		at 12 months follow-up
Secondary	change in height z-score		at 6 months follow-up
Secondary	change in height z-score		at 12 months follow-up
Secondary	change in Autism Spectrum Screening Questionnaire (ASSQ) score	symptoms of autism	at 3 months follow-up
Secondary	change in Autism Spectrum Screening Questionnaire (ASSQ) score	symptoms of autism	at 1 months follow-up
Secondary	change in Autism Spectrum Screening Questionnaire (ASSQ) score	symptoms of autism	at 6 months follow-up
Secondary	change in Autism Spectrum Screening Questionnaire (ASSQ) score	symptoms of autism	at 12 months follow-up