Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The PACS study aims to investigate the efficacy and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety.

The study design is an 8 week flexible dosage, randomized placebo controlled.

The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients are recruited from outpatient clinics from entire Denmark.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University; GCP-unit at Aarhus University Hospital, Aarhus, Denmark; Pfizer; The Hospital Pharmcacy North Denmark Region, Denmark
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Ages 18-65 years

• An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9

• Stable dosage of psychotropic 4 weeks before inclusion

• Hamilton Anxiety Scale total score > 15

• Positive and Negative Syndrome Scale for Schizophrenia total score < 70

• The Calgary Depression Scale for Schizophrenia total score < 10

• Fertile women: Contraception during the trial

• S-creatinin within normal reference range

• Signed informed consent and power of attorney

Exclusion Criteria:

• Significant substance abuse

• QTc > 480 milliseconds

• Severe dysregulated diabetes

• For women: Pregnancy or breast-feeding

• Confinement in accordance with the Danish Law of Psychiatry

• Concrete suicidally

• Known hypersensitivity or allergic reaction to the active ingredient of the drug