Memantine Add-On Therapy to Clozapine

Phase 2

Completed

• Conditions: in het bijzonder therapieresistente schizofrenie (langer dan 6 maanden ingesteld op clozapine); clozapine-refractory schizophrenia - treatment resistant schizophrenia; 10039628

• Registration Number: NL-OMON39302
• Lead Sponsor: GGZ NH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 52

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.

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 less than 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
• Study Design: Not specified