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

Chronic Schizophrenia Clinical Trial

Official title:

Memantine add-on to Risperidon for Treatment of Negative Symptoms and Cognitive Dysfunction in Patients With Chronic Schizophrenia: Results of a Proof of Concept Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00148616
• Other study ID #: MIND 2
• Secondary ID: 02T-247 (SMRI)
• Status: Terminated
• Phase: Phase 3
• Start date: April 2004
• Est. completion date: December 2008

Study information

• Verified date: June 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Schizophrenia
• Cognitive Dysfunction
• Schizophrenia

Intervention

Drug:
• Memantine
Daily dosage of 20 mg Memantine add-on to Risperidone vs. Placebo add-on to Risperidone
• Placebos
Daily dosage of 20 mg Placebo add-on to Risperidone vs. Memantine add-on to Risperidone

Locations

Country	Name	City	State
Germany	Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
M. Schaefer, MD	Stanley Medical Research Institute

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in PANSS negative subscore between memantine and placebo treatment		during trial