Schizophrenia Clinical Trial
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
Verified date | June 2019 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 24 |
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 - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy | Berlin |
Lead Sponsor | Collaborator |
---|---|
M. Schaefer, MD | Stanley Medical Research Institute |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in PANSS negative subscore between memantine and placebo treatment | during trial |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |