Pregablin for Anxiety-comorbidity in Patients With Schizophrenia (PACS)

January 6, 2017 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9220
        • Aalborg University Hospital, Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pregabalin
The pregabalin dose is 75 mg daily the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response.
Drug: Pregabalin
Subjects are randomized 1:1 to either pregabalin treatment or placebo. The intervention period is 8 weeks. The daily pregabalin dose is 75 mg. during the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response. Doses above 150 mg. should be divided in two daily dosages.
Other Names:
  • Brand name: Lyrica(R)
Placebo Comparator: Pregabalin Placebo Capsules
Drug: Pregabalin Placebo Capsules
Parallel to Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Anxiety Scale
Time Frame: Baseline - 4 weeks treatment - 8 weeks treatment
Baseline - 4 weeks treatment - 8 weeks treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
UKU-Overall adverse effect scale
Time Frame: Baseline - 4 weeks treatment - 8 weeks treatment
Baseline - 4 weeks treatment - 8 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Albert Einstein College of Medicine
Pfizer
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
The Hospital Pharmcacy North Denmark Region, Denmark

Investigators

  • Principal Investigator: Ole Schjerning, M.D., Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eudra CT nr 2010-024488-42
  • N-20100097 (Other Identifier: The North Denmark Region Committee on Health Research Ethics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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