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Glutamatergic medication in the treatment of Obsessive Compulsive Disorder (OCD) and Autism Spectrum Disorder (ASD)

Glutamatergic medication in the treatment of Obsessive Compulsive Disorder (OCD) and Autism Spectrum Disorder (ASD) - GOAT studies in TACTICS

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41943
Enrollment
48
Registered
2015-12-21
Start date
2017-01-11
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Obsessief Compulsieve Stoornis Autism Spectrum Disorder and Obsessive Compulsive Disorder

Interventions

This study involves a comparison of an active drug (memantine) with matching placebo. During Study Period II, medication will be initiated and modified according to the weight group of the patient a

Sponsors

Radboudumc, Donders Institute of Brain, Cognition and Behavior
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: ASD and OCD inpatients or outpatients Age 6 (ASD) or 8 (OCD) untill 17;9 years at initial inclusion CGI-S score >/

Exclusion criteria

Exclusion criteria: Body weight

Design outcomes

Primary

MeasureTime frame
Primary endpoints are measures of * Baseline-to-endpoint change in symptoms/scale scores of compulsivity (CY-BOCS Total score), * adverse event rates and profile (spontaneous reporting, structured (short) AE scale, laboratory measures).

Secondary

MeasureTime frame
Genotypes of single common and rare variants in candidate genes, and also combined genetic variants in whole genes or neurotransmitter systems / gene pathways; Further lab assessments of various proteins in blood plasma.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)