Clinical Trial Details

NCT ID: NCT01496690
Date Last Changed: August 8, 2016


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

Recruitment Details

Both Male and Female
18 to 65 Years
Overall Status
Lead Sponsor
University of Aarhus
59 Months
Facility Type


Both Male and Female ages 18 Years to 65 Years

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

Site Locations (1)

Country State City Zip Facility and Contact
Denmark Aalborg 9220 Aalborg University Hospital, Aalborg Psychiatric Hospital, Centre for Schizophrenia
Jimmi Nielsen, M.D

Jimmi Nielsen, M.D.
Principal Investigator

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