Memantine for the Treatment of Cognitive Dysfunction and Negative Symptoms in Patients With Chronic Schizophrenia

NCT ID: NCT00148616

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 24 weeks memantine add-on treatment to risperidone for the treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia.

Detailed Description

This study examines the efficacy and safety of 24 weeks memantine add-on treatment to risperidone for the treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia. The trail was double-blind, prospective, randomized, placebo-controlled, parallel-group and consisting of a 'placebo-run-in' period, treatment, and follow-up periods. Study personnel and participants were blinded to group assignment. In the 'run-in' period, patients received Lorazepam for the treatment of anxiety and tension states for two weeks before starting antipsychotic therapy. After the 'run-in' period treatment, patients began receiving antipsychotic therapy with Risperidon with continuous concomitant administration of a 24 weeks Memantine, 20 mg/d, or placebo. Adherence was assessed at each clinic visit by pill count. In cases of anxiety and tension states, an experienced psychiatrist decided whether patients should receive Lorazepam, 5 mg/d, as rescue medication in addition to the study medication (Memantine or placebo), to which the patients remained blinded. In cases of pseudo parkinsonism patients were allowed to receive Biperiden, up to 8 mg/d, and for the treatment of patients suffering from sleep disorders Zopiclon (15 mg/d) was allowed. The consumption of alcohol and drugs were not allowed during the trial. In both study parts, psychiatric assessments were performed at baseline as well as after 2; 4; 6; 12 and 24 weeks after treatment (that is, during the follow-up period). The neuropsychological examination was performed at baseline, and after 6 and 24 weeks. Psychiatric changes, adverse events, laboratory values, dose adjustments of the antipsychotic therapy, and possible pharmacologic adverse effects were systematically monitored throughout the study.

Conditions

Chronic Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Memantine plus Risperidone

24 weeks memantine add on treatment to risperidone

Group Type: ACTIVE_COMPARATOR

Memantine

Intervention Type: DRUG

Daily dosage of 20 mg Memantine add-on to Risperidone vs. Placebo add-on to Risperidone

Placebo plus Risperidone

24 weeks placebo add on treatment to risperidone

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Daily dosage of 20 mg Placebo add-on to Risperidone vs. Memantine add-on to Risperidone

Interventions

Memantine

Daily dosage of 20 mg Memantine add-on to Risperidone vs. Placebo add-on to Risperidone

Intervention Type: DRUG

Placebos

Daily dosage of 20 mg Placebo add-on to Risperidone vs. Memantine add-on to Risperidone

Intervention Type: DRUG

Other Intervention Names

Akatinol; Placebo

Eligibility Criteria

Inclusion Criteria

• Diagnosis of schizophrenia (DSM-IV)
• Age 18 to 40
• Stable negative syndrome (PANSS negative score > 20)
• At least one previous schizophrenic episode
• Informed consent
• Subjects must be considered by the investigator to be compliant with investigations and appointments
• Subjects must have an educational level and a degree of understanding such that they can meaningfully communicate with the investigator

Exclusion Criteria

• Axis I disorder other than schizophrenia within 12 months, e.g. schizoaffective disorder
• Severe positive symptomatology (PANNS positive score > PANNS negative score)
• Dependency on alcohol or addictive drugs within 6 months of the baseline evaluation
• Contraindication of risperidone
• Significant neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

M. Schaefer, MD

OTHER

Sponsor Role: lead

Responsible Party

M. Schaefer, MD

Professor of Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Schaefer, MD

Role: PRINCIPAL_INVESTIGATOR

Charite Campus Mitte; Dept. of Psychiatry and Psychotherapy and Department of Psychiatry, Kliniken Essen-Mitte, Essen

Locations

Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy

Berlin, , Germany

Countries

Germany

References

Schaefer M, Sarkar S, Theophil I, Leopold K, Heinz A, Gallinat J. Acute and Long-term Memantine Add-on Treatment to Risperidone Improves Cognitive Dysfunction in Patients with Acute and Chronic Schizophrenia. Pharmacopsychiatry. 2020 Jan;53(1):21-29. doi: 10.1055/a-0970-9310. Epub 2019 Aug 7.

Reference Type: DERIVED

PMID: 31390660 (View on PubMed)

Other Identifiers

02T-247 (SMRI)

Identifier Type: -

Identifier Source: secondary_id

MIND 2

Identifier Type: -

Identifier Source: org_study_id