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Clinical Trial Details
Research Study Summary
A clinical trial to evaluate treatments using Pregabalin and Pregabalin Placebo Capsules for patients with Schizophrenia or Anxiety-comorbidity to Schizophrenia
Research Study Title
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.
To Learn more
Both Male and Female
Both Male and Female ages 18 Years to 65 Years
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
Significant substance abuse
QTc > 480 milliseconds
Severe dysregulated diabetes
For women: Pregnancy or breast-feeding
Confinement in accordance with the Danish Law of Psychiatry
Known hypersensitivity or allergic reaction to the active ingredient of the drug
Site Locations (1)
||Aalborg University Hospital, Aalborg Psychiatric Hospital, Centre for Schizophrenia
Jimmi Nielsen, M.D
Jimmi Nielsen, M.D.
NCT ID: NCT01496690
Date Last Changed: May 30, 2014
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