Clinical Trial of Dipyridamole in Schizophrenia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Drug: Dipyridamole Other: Olanzapine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Clinical Trial of Dipyridamole in Schizophrenia |
- 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. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- To determine if dipyridamole, a clinically available adenosine agonist, has efficacy for treating positive and negative symptoms and cognitive deficits of schizophrenia. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 29 |
| Study Start Date: | May 2001 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Dipyridamole
|
Drug: Dipyridamole
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
Olanzapine
|
Other: Olanzapine
Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Human Research Protections Office, Associate Professor, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT00349973 History of Changes |
| Other Study ID Numbers: | HP-00043347 |
| Study First Received: | July 5, 2006 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Maryland:
|
Schizophrenia Positive symptoms Negative symptoms Cognitive deficits |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Psychotic Disorders Mental Disorders Dipyridamole Olanzapine Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Vasodilator Agents Cardiovascular Agents |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013