Clinical Trial of Dipyridamole in Schizophrenia
Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
Intervention: Dipyridamole (Drug); Olanzapine (Other)
Phase: N/A
Status: Completed
Sponsored by: University of Maryland Official(s) and/or principal investigator(s): Ikwunga Wonodi, MD, Study Director, Affiliation: Maryland Pschiatric Research Center, University of Maryland School of Medicine Gunvant K Thaker, MD, Principal Investigator, Affiliation: University of Maryland
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.
Clinical Details
Official title: Clinical Trial of Dipyridamole in Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: To provide preliminary estimates of effect sizes of dipyridamole on positive symptoms, negative symptoms, and cognitive deficits differ between schizophrenia patients treating with dipyridamole, and schizophrenia patients treated with olanzapine.
Secondary outcome: To determine if dipyridamole, a clinically available adenosine agonist, has efficacy for treating positive and negative symptoms and cognitive deficits of schizophrenia.
Detailed description:
Since the demonstrated success of chlorpromazine in treating psychosis in the1950's, 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects between ages 18-65, both males and nonpregnant females (on birth control)
Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder Ability to
give written informed consent Total BPRS score > 27 Psychosis subscale scores > 7
Exclusion Criteria:
- Patients with coagulative disorders, bleeding diathesis or currently on
anticoagulants, and patients with major medical illnesses (including hypertension,
angina, and cardiovascular diseases) or an abnormal baseline ECG.
Patients with moderate to severe mental retardation.
Inability to sign informed consent.
Patients with a history of serious violence (e. g., suicide attempts, or assaultive
behavior).
Patients on clozapine treatment within the 6 weeks leading to the double-blind phase.
Patients with a history of olanzapine non-response
Positive Urine Toxicology Screen
Locations and Contacts
Maryland Psychiatric Research Center, Baltimore, Maryland 21228, United States
Additional Information
Maryland Psychiatric Research Center
Starting date: May 2001
Last updated: January 11, 2013
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