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Home » Clinical Trials » Anxiety Disorders

Clinical Trial Details

Overview

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

Purpose

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
Phase

4

Gender

Both Male and Female

Age

18 to 65 Years

Overall Status

Recruiting

Lead Sponsor

University of Aarhus

Duration

35 Months

Facility Type

N/A

Eligibility

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
+4572137233
jin@rn.dk

Jimmi Nielsen, M.D.
Principal Investigator

NCT ID: NCT01496690

Date Last Changed: May 30, 2014

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