Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349973
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2006-07-05
Brief Title:
Clinical Trial of Dipyridamole in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Clinical Trial of Dipyridamole in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2019-10
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:
This is a 6-week randomized double blind parallel groups designed olanzapine-controlled trial of oral dipyridamole in symptomatic patients with a DSM IV diagnosis of schizophrenia schizoaffective or schizophreniform disorder This pilot study aims to provide preliminary estimates of whether the effect sizes of dipyridamole on positive symptoms negative symptoms and cognitive deficits differ between schizophrenia patients treated with dipyridamole and schizophrenia patients treated with olanzapine A total of 30 subjects will be recruited locally
Detailed Description:
Since the demonstrated success of chlorpromazine in treating psychosis in the1950s the pharmacotherapy of schizophrenia has focused mainly on drugs with antidopaminergic actions These drugs have robust effects on reality distortion and disorganization symptom complexes but minimal effect on cognitive impairment negative symptoms and functional outcome and quality of life measures Newer generation antipsychotic drugs have a similar profile of effects with some advantages on the course of depression hostility suicide hospital readmission rates and motor side effect measures Side effects such as weight gain increase in cardiovascular stress and diabetes risk are associated with some new generation drugs A new class of drugs is needed to address the inadequate effectiveness and the side-effect disadvantages of the currently available pharmacological agents for the treatment of schizophrenia Recently new treatment strategies using nicotinergic drugs or agonists at the glycine modulatory site of the glutamatergic N-methyl-D-aspartate NMDA receptor have been employed in clinical trials with mixed results Our proposal focuses on a clinically available adenosine agonist dipyridamole in a 6-week clinical trial Published data suggest effectiveness of dipyridamole in treating psychosis when added to haloperidol treatment The effectiveness of dipyridamole alone in treating schizophrenia symptoms although indirectly suggested by several lines of evidence has not been tested
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