Memantine for the Prevention of Negative Symptomatology

This study is currently recruiting participants.

Verified by Charite University, Berlin, Germany, September 2008

Sponsors and Collaborators:	Charite University, Berlin, Germany Stanley Medical Research Institute
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00148590

Purpose

The purpose of this study is to evaluate the efficacy and safety of memantine as add-on treatment for the prevention of negative symptomatology in patients with an acute exacerbation of schizophrenia.

Primary outcome parameter are negative symptoms after 6 months

Condition	Intervention	Phase
Schizophrenia	Drug: Memantine Drug: Placebo	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Memantine Memantine hydrochloride Glutamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Memantine for the Prevention of Negative Symptomatology and Cognitive Impairment in Schizophrenia

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Changes in PANSS negative subscore between memantine and placebo treatment [ Time Frame: during trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Memantine Daily dose of 10mg memantine Vs. Placebo
Placebo: Placebo Comparator	Drug: Placebo Daily dose of 10mg memantine Vs. Placebo

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148590

Contacts

Contact: Martin Schaefer, MD

+49-201-174-2200

martin.schaefer@charite.de

Locations

Germany
Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy	Recruiting
Berlin, Germany, 10117
Contact: Michael Krebs, MD +49-30-450-517198 michael.krebs@charite.de
Contact: Karolina Leopold, MD +49-30-450-517198 karolina.leopold@charite.de
Sub-Investigator: Michael Krebs, MD
Sub-Investigator: Karolina Leopold, MD

Sponsors and Collaborators

Charite University, Berlin, Germany

Stanley Medical Research Institute

Investigators

Principal Investigator:

Martin Schaefer, MD

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

More Information

Responsible Party:	Charite University, Berlin, Germany ( Martin Schaefer, MD )
Study ID Numbers:	MIND 1, 02T-247 (SMRI)
Study First Received:	September 7, 2005
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00148590
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

Memantine
Negative syndrome
Schizophrenia
Cognitive impairment
Glutamate

Study placed in the following topic categories:

Schizophrenia
Excitatory Amino Acids
Dopamine
Mental Disorders

Memantine
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Antiparkinson Agents

Excitatory Amino Acid Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009