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

Phase 1

• Conditions: Obsessive Compulsive Disorders (OCD) Autism Spectrum Disorders (ASD); MedDRA version: 19.1Level: PTClassification code 10063844Term: Autism spectrum disorderSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 19.1Level: PTClassification code 10029898Term: Obsessive-compulsive disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-003080-38-GB
• Lead Sponsor: Radboud University, Nijmegen Medical Centre, Donders Institute for Brain, Cognition and Behaviour

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-16
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Male and female patients
Inpatient or outpatient status
Aged 6;0 y. (ASD patients) / 8;0 y. (OCD patients) - 17.9 years at initial inclusion
IQ = 70 (if an IQ-test was not done within 2 y from Baseline visit, the IQ assessment should be based on Wechsler scales, 4 subtests, cf. 5.1.3)
CGI-S score >/= 4 (moderately ill; anchored to respective disorder) at Baseline (BL, visit 3)
Ability to speak and comprehend the native language of the country in which the assessments take place
Signed informed consent by parents or legal representative
Signed informed assent by patients (indicating that the subject is aware of the investigational nature and the core aspects of the study and the study is run in accordance with the ICH GCP guideline E6 (1996))
Female subject must not have a positive beta HCG pregnancy test at screening, and must have a negative urine pregnancy test at baseline (BL), and agree to comply with applicable contraceptive requirements
Inclusion criteria for subjects with OCD (GOAT_1): DSM-5 diagnosis of OCD (APA, 2013), according to a systematic interview, e.g., DISC interview, k-SADS
Inclusion criteria for subjects with ASD (GOAT_2): DSM-5 diagnosis of ASD (APA, 2013), according to ADI-R interview (shortened version, focusing on criteria for diagnostic decision)
Are the trial subjects under 18? yes
Number of subjects for this age range: 26
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Mental retardation (IQ < 70)
Body weight < 20kg at baseline (BL)
Major physical illness of the cardiovascular, endocrine, pulmonary, or the gastrointestinal system
Contra-indications for memantine, according to the Summary of Product characteristics (SPC)
History of or present clinically relevant somatic acute or chronic disorder that, in the opinion of the investigator, might confound the results of olerability/safety assessment, or prohibit the patients from completing the study, or would not be in the best interest of the patient.
Subject has failed to respond, based on investigator judgement, to an earlier adequate course (dose and duration) of the investigational drug therapy, memantine.
Subject has a documented allergy, hypersensitivity, or intolerance to memantine.
Subject has a lactose intolerance.
Subject has a positive urine drug screen result at screening or BL (apart from earlier prescribed medication; retest and negative result at BL needed then)
Subject has taken another investigational product or taken part in a clinical study with 30 days prior to screening
Subject is female and is pregnant or lactating
For those subjects intending to participate in the neuroimaging assessments: All contra indications for MRI assessment, such as the presence of metal objects in or around the body (pacemaker, dental braces)

Patients/parents will not be excluded from the study(ies) in case they do not agree to participate in certain sets of assessments (e.g., neuroimaging, blood sampling for bioanalytical analyses).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified