Schizophrenia Clinical Trial
Official title:
The Phosphodiesterase Inhibitor Pentoxifylline as an Adjunctive in Treatment of Negative Symptoms in Chronic Schizophrenia: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Verified date | October 2022 |
Source | Sadat City University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study to evaluate the efficacy and safety of pentoxifylline, the novel phosphodiesterase inhibitor, as an adjunctive to risperidone in alleviating the negative symptoms of schizophrenia.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Ages between 18-40 years - Males & females - patients between the ages of 18 and 53 who met the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (20), with a minimum disease duration of two years. - stable on risperidone for a minimum of 8 weeks - clinically stable for at least 4 weeks prior to study. - willing to give informed consent. - able to take medication orally. Exclusion Criteria: - Acute, unstable, significant or untreated medical illness beside schizophrenia; - Pregnant or breast-feeding females; - History of substance abuse or dependence in the past 3 months. - Known contraindication to pentoxifylline treatment. - Any serious or life-threatening medical conditions or neurological problem, severe extrapyramidal symptoms, history of abnormal bleeding, presence of hypothyroidism, renal disease, cardiovascular problems, rising liver transaminases to 3 times the upper limit of normal or higher |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine | Shibin Al Kawm |
Lead Sponsor | Collaborator |
---|---|
Sadat City University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment-induced change in total score on Positive and Negative Syndrome Scale (PANSS) | PANSS total score will be used to examine treatment-induced change in psychaopthology. The PANSS is a 30-item rating scale used to assess symptoms of psychopathology. We will use the total PANSS score as the primary outcome measure which reflects total level of psychopathology including the positive and negative symptoms as well as general psychopathology.This measure will be administered at baseline, week 8 and week 16 of the study to assess if pentoxifylline treatment results in a significant reduction in PANSS total score as opposed to placebo. | Baseline to week 8 of the study | |
Secondary | Treatment-induced changes in plasma level of cytokines | Cytokine levels will assessed at baseline and week 8 of the study to examine treatment-induced changes in neuroinflammation. | Baseline and week 8 of the study |
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