Viewing Study NCT00148590



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Last Modification Date: 2024-10-26 @ 9:14 AM
Study NCT ID: NCT00148590
Status: TERMINATED
Last Update Posted: 2019-06-27
First Post: 2005-09-07

Brief Title: Memantine for the Prevention of Cognitive Dysfunction and Negative Symptoms in Patients With Acute Schizophrenia
Sponsor: M Schaefer MD
Organization: Charite University Berlin Germany

Study Overview

Official Title: Memantine add-on to Risperidon for Treatment of Negative Symptoms and Cognitive Dysfunction in Patients With Acute Schizophrenia Results of a Proof of Concept Study
Status: TERMINATED
Status Verified Date: 2019-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: This study examines 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 The trail is 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 Memantine 20 mgd or placebo for six weeks 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 mgd 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 mgd and for the treatment of patients suffering from sleep disorders Zopiclon 15 mgd 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
02T-247 SMRI None None None