N/A N=20 Randomized Double-blind Treatment

Clinical Trial of Dipyridamole in Schizophrenia

Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00349973 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Change in Positive Symptoms by Treatment Assignment — 2.222; 1.400; 1.60; 1.00 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dipyridamole (Drug); Olanzapine (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Positive Symptoms by Treatment Assignment	2.222; 1.400; 1.60; 1.00; 2.667; 2.600	—
PRIMARY Change in Negative Symptoms by Treatment Assignment	23.3; 25.6; 25.8; 27.0	—
PRIMARY The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	73.00; 59.00; 77.40; 65.00	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00349973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.