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

M

M. Schaefer, MD

Status and phase

Terminated
Phase 3

Conditions

Chronic Schizophrenia

Treatments

Drug: Memantine
Drug: Placebos

Study type

Interventional

Funder types

Other

Identifiers

NCT00148616
02T-247 (SMRI)
MIND 2

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

13 participants in 2 patient groups, including a placebo group

Memantine plus Risperidone
Active Comparator group
Description:
24 weeks memantine add on treatment to risperidone
Treatment:
Drug: Memantine
Placebo plus Risperidone
Placebo Comparator group
Description:
24 weeks placebo add on treatment to risperidone
Treatment:
Drug: Placebos

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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