Clinical Trial of Dipyridamole in Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/12/2018 |
| Start Date: | May 2001 |
| End Date: | September 2011 |
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.
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.
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.
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.
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
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