Clinical Trial of Dipyridamole in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00349973|
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : December 10, 2018
Last Update Posted : November 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Schizophreniform Disorder||Drug: Dipyridamole Other: Olanzapine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Trial of Dipyridamole in Schizophrenia|
|Study Start Date :||May 2001|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2011|
Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
Active Comparator: 2
Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
- Change in Positive Symptoms by Treatment Assignment [ Time Frame: Baseline and follow-up ]The Brief Psychiatric Rating Scale (BPRS) consists of 20 items, with 6 of these items used to assess positive symptom change. The BPRS positive symptom items are: somatic concern, conceptual disorganization, hostility, suspiciousness, hallucinatory behavior, and unusual thought content. Each scale ranges from "1=Not Present" to "7=Very Severe". A higher score indicates a more severe positive symptom rating.
- Change in Negative Symptoms by Treatment Assignment [ Time Frame: Baseline and Follow-Up ]The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Mean SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
- The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline and Follow-Up ]The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349973
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Baltimore, Maryland, United States, 21228|
|Study Director:||Ikwunga Wonodi, MD||Maryland Pschiatric Research Center, University of Maryland School of Medicine|
|Principal Investigator:||Gunvant K Thaker, MD||University of Maryland, College Park|