The Phosphodiesterase Inhibitor Pentoxifylline as an Adjuvant in Treatment of Negative Symptoms in Chronic Schizophrenia

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sadat City University
• Treatments: Pentoxifylline

Criteria

Inclusion Criteria:

• Ages between 18-40 years

• Males & females

• Current DSM-IV diagnosis of schizophrenia or schizoaffective disorder confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) conducted by a trained psychiatrist.

• Treatment with a stable dose of second generation antipsychotic medication for at least 1 months prior to study entry 200-600 mg/day chlorpromazine equivalent doses);

• Evidence of stable symptomatology for 12 weeks as evidenced by no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms, no ER use for symptoms of schizophrenia and no significant changes to antipsychotic medication or dose (>25%) in the past 12 weeks.

• Baseline total score between 40 and 65 on the Brief Psychiatric Rating Scale (BPRS); Raw score of 12 or higher on the Wechsler Test of Adult Reading (WTAR) (estimates premorbid IQ).

• Able to comprehend the procedure and aims of the study to provide informed consent

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