N/A
Completed N=20
Clinical Trial of Dipyridamole in Schizophrenia
Schizophrenia · schizoaffective disorder · Schizophreniform Disorder
Source: ClinicalTrials.gov NCT00349973 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Change in Positive Symptoms by Treatment Assignment — 2.222; 1.400; 1.60; 1.00 units on a scale
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.
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 | — |
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
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. Informational only — not medical advice.