Clinical Trial of Dipyridamole in Schizophrenia

NCT00349973 | Completed Results DMC

• 1 other identifier: HP-00043347
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

Schizophrenia; Positive symptoms; Negative symptoms; Cognitive deficits

Outcome Measures

Primary Outcomes (3)

• Change in Positive Symptoms by Treatment Assignment

  The Brief Psychiatric Rating Scale (BPRS) consists of 20 items, with 6 of these items used to assess positive symptom change. The BPRS positive symptom items are: somatic concern, conceptual disorganization, hostility, suspiciousness, hallucinatory behavior, and unusual thought content. Each scale ranges from "1=Not Present" to "7=Very Severe". A higher score indicates a more severe positive symptom rating.

  Baseline and follow-up

• Change in Negative Symptoms by Treatment Assignment

  The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Mean SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.

  Baseline and Follow-Up

• The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.

  Baseline and Follow-Up

Study Arms (2)

1

EXPERIMENTAL

Dipyridamole

Drug: Dipyridamole

2

ACTIVE COMPARATOR

Olanzapine

Other: Olanzapine

Interventions

Dipyridamole DRUG

Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm

1

Olanzapine OTHER

Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Maryland Psychiatric Research Center

Baltimore, Maryland, 21228, United States

Location

Related Publications (3)

• Akhondzadeh S, Shasavand E, Jamilian H, Shabestari O, Kamalipour A. Dipyridamole in the treatment of schizophrenia: adenosine-dopamine receptor interactions. J Clin Pharm Ther. 2000 Apr;25(2):131-7. doi: 10.1046/j.1365-2710.2000.00273.x.

  PMID: 10849191 RESULT

• Dixon DA, Fenix LA, Kim DM, Raffa RB. Indirect modulation of dopamine D2 receptors as potential pharmacotherapy for schizophrenia: I. Adenosine agonists. Ann Pharmacother. 1999 Apr;33(4):480-8. doi: 10.1345/aph.18215.

  PMID: 10332540 RESULT

• Ferre S. Adenosine-dopamine interactions in the ventral striatum. Implications for the treatment of schizophrenia. Psychopharmacology (Berl). 1997 Sep;133(2):107-20. doi: 10.1007/s002130050380.

  PMID: 9342776 RESULT

Related Links

• Maryland Psychiatric Research Center

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Cognition Disorders

Interventions

Dipyridamole; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Elliot Hong, Prinicipal Investigator
• Organization: University of Maryland, Baltimore

ehong@som.umaryland.edu

410-402-6828

Study Officials

• Ikwunga Wonodi, MD

  Maryland Pschiatric Research Center, University of Maryland School of Medicine

  STUDY DIRECTOR

• Gunvant K Thaker, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: May 1, 2001
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2011
• Last Updated: November 4, 2019
• Results First Posted: December 10, 2018

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)