Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study

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.

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