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Long-term effects of psychotropic medication on the developing brain. A cohort study based on medical prescription data

Long-term effects of psychotropic medication on the developing brain. A cohort study based on medical prescription data - ePOD-IPCI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36448
Enrollment
150
Registered
2011-11-02
Start date
2011-05-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bijwerkingen van medicijnen ADHD MDD and anxietydisorders

Interventions

None listed

Sponsors

Radiologie, Div I
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Exposed group: Females aged 23-30 years who have been treated with fluoxetine or another SSRI before age 16 (preferably at age 12-14) or treated at 23-30 years, presumably for treatment of moderate to severe MDD or anxiety disorder. Males aged 23-30 years who have been treated with methylphenidate before age 16 (preferably at age 10-12) or treated at age 23-30, presumably for treatment of ADHD. Unexposed groups: There will be two unexposed groups 23-30 years of age consisting of drugnaive subjects suffering from ADHD or MDD/anxiety disorder.

Exclusion criteria

Exclusion criteria: -IQ

Design outcomes

Primary

MeasureTime frame
Primary study parameters/endpoints: - phMRI: difference in % change in ASL signal from baseline evoked by an acute pharmacological challenge between cases and control groups. - DTI: difference in FA and MD values between cases and control groups. - Resting state fMRI (rs-fMRI): difference in functional connectivity (FC) within specific (DA and 5-HT) neuronal networks

Secondary

MeasureTime frame
Secondary study parameters/endpoints: -fMRI: difference in task related BOLD signal between cases and control groups -Neuropsychological functioning: difference between cases and control groups in outcome of several well-validated neuropsychological (computer) tasks addressing emotional processing and impulsivity/behavioral inhibition compared to baseline measurements. -genetic and cortisol sampling

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)