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

Phase 2

Completed

• Conditions: Refractory schizophrenia with a non-satisfactory response to clozapine after a treatment duration of at least six months; Mental and Behavioural Disorders

• Registration Number: ISRCTN14760638
• Lead Sponsor: Mental Health Service Organisation North Holland North, Community Mental Health Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-12
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

The inclusion criteria for the proof-of-concept study include:
1. Outpatients (including sheltered housing) and patients living in long-stay wards
2. Both sexes
3. Age 18 to 60
4. Meeting DSM-IV criteria for schizophrenia, based on the definitions in the Mini International Neuropsychiatric Interview Plus (MINI-Plus) with persistent residual psychopathology
5. Failing to achieve the remission criteria (remission is defined as simultaneous ratings of mild or less (= 3 points) on eight 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)
6. 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
7. Able to understand the study information and procedures and give informed consent.

The inclusion criteria for the follow-up study include:
1. Completer of the proof-of-concept study.
2. Memantine is only administered to patients who have experienced clinical improvement after 12 weeks of memantine addition in the proof-of-concept study.

Exclusion Criteria

1. Patients admitted at acute treatment wards
2. Pregnancy
3. Lactating women
4. Female subjects without adequate contraception
5. Known hypersensitivity to memantine
6. Co-medication with glutamate modulators
7. Lactose intolerance
8. Uncontrolled epilepsy
9. Myocardial infarction
10. Uncontrolled hypertension
11. Renal insufficiency
12. Severe liver failure
13. Moderate or severe Alzheimer’s disease
14. Extremely ill patients (Global Assessment of Functioning [GAF] = 20), who are not reliably able to give their informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified