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

Recruiting

• Conditions: bijwerkingen van medicijnen; ADHD; MDD and anxietydisorders; 10042258

• Registration Number: NL-OMON36448
• Lead Sponsor: Radiologie, Div I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

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

-IQ < 70 (National Adult Reading Test (NART); Nelson, 1991).
-Alcohol and/or drug dependence according to DSM-IV criteria.
- Contraindications to MRI scanning (any kind of irremovable metal inside the body (including piercings, (large) tattoo*s, brackets, etc.), neurological disorders (e.g. epilepsy), claustrophobia).
-In case of female subjects: pregnancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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