NCT00148590

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of a 6 weeks memantine add-on to risperidon treatment for the prevention of cognitive dysfunction and negative symptomatology in patients with acute schizophrenia. Psychopathological changes were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and after 2, 4, 6, 12, and 24 weeks. Cognitive function were measured at baseline and week 6, and 24 by the California Verbal Learning Test, Benton Learning Test, Digit Span Forward and Backward Test, Continuous Performance Test, Stroop Test, Trail-Making Test, Verbal Fluency Test, and Wisconsin Card Sorting Test.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Nov 2005

Typical duration for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

2.6 years

First QC Date

September 7, 2005

Last Update Submit

June 25, 2019

Conditions

Schizophrenia

Keywords

MemantineNegative syndromeSchizophreniaCognitive impairmentGlutamate

Outcome Measures

Primary Outcomes (1)

  • Changes in PANSS negative subscore between memantine and placebo treatment

    during trial

Study Arms (2)

Memantine plus Risperidone

ACTIVE COMPARATOR

6 weeks 20 mg Memantine as add-on treatment to Risperidone

Drug: Memantine

Placebo plus Risperidone

PLACEBO COMPARATOR

6 weeks 20 mg Placebo as add-on treatment to Risperidone

Drug: Placebo

Interventions

MemantineDRUG

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

Also known as: Akatinol
Memantine plus Risperidone
PlaceboDRUG

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

Placebo plus Risperidone

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Axis I disorder other than schizophrenia within 12 months, e.g. schizoaffective disorder
  • Severe negative symptomatology (PANNS negative score \>20 points)
  • Duration of schizophrenia \> 5 years
  • 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
  • Prior ECT-treatment, metal implantations
  • Female subjects during pregnancy and breastfeeding
  • Female subjects within childbearing years who were not using adequate birth control
  • Patients who are judged by the investigator to be at serious suicide risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31390660DERIVED

MeSH Terms

Conditions

SchizophreniaCognitive Dysfunction

Interventions

Memantine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Martin Schaefer, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

November 1, 2005

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

DE(1)