Memantine as an adjunctive therapy to ongoing clozapine treatment: a proof-of-concept study

• Conditions: Cognitive functioning, severity of psychopathology and treatment response (positive symptoms and negative symptoms of schizophrenia), depressive symptoms, social cognition, obsessive-compulsive symptoms, psychosocial functioning, quality of life and adverse effects in outpatients with refractory schizophrenia and a nonsatisfactory response to clozapine (duration of adequate clozapine treatment at least six months).; MedDRA version: 17.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-003466-33-NL
• Lead Sponsor: Mental Health Services North Holland North

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-29
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Eligible for the study are outpatients, both sexes, age 18 to 60, meeting DSM-IV criteria for schizophrenia, based on the definitions in the Mini International Neuropsychiatric Interview Plus (MINI-Plus) with persistent residual psychopathology, failing to achieve the remission criteria, after adequate treatment with clozapine for at least 6 months. Before the start of the study clozapine plasma concentration has been at least 350 ng/ml for 12 weeks or has not reached 350 ng/ml due to intolerability. Remission defined as simultaneous ratings of mild or less (= 3 points) on 8 of the PANSS items evaluating the core symptoms of schizophrenia (P1 delusions, G9 unusual thought content, P3 hallucinatory behaviour, P2 conceptual disorganisation, G5 mannerisms and posturing, N1 blunted affect, N4 passive or apathetic social withdrawal, N6 lack of spontaneity and flow of conversation) (Os van and Kahn, 2007). Patients should be able to understand the study information and procedures and give informed consent. All participants fulfilling the inclusion and not fulfilling the exclusion criteria may, after a detailed description by a doctor and the written declaration of informed consent on an according form, participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnancy.
- Lactating women.
- Female subjects without adequate contraception.
- Known hypersensitivity to memantine or ingredients used in this tablet.
- Uncontrolled epilepsy.
- Recent myocardial infarction.
- Uncontrolled hypertension.
- Renal insufficiency (GFR < 30 ml/min).
- Severe liver failure (ASAT 175 U/l and/or ALAT 225 U/l in men and 175 U/l in women).
- Lactose intolerance.
- Co-medication with NMDA-antagonists such as amantadine, ketamine, dextromethorphan.
- Co-medication with glutamate antagonists such as lamotrigine and topiramate.
- Extremely ill patients (Global Assessment of Functioning [GAF] = 20), who are not reliably able to give their informed consent.
- Moderate or severe Alzheimer’s disease.

Study & Design

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