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Completed

NCT Number: NCT01496690

Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

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.

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Key information

Conditions

Schizophrenia Anxiety-comorbidity to Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg University Hospital, Psychiatry

Aalborg, 9220, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

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)

Pregabalin Placebo Capsules

Drug

Parallel to Active Comparator

Primary outcomes

  1. Hamilton Anxiety Scale

    Time frame: Baseline - 4 weeks treatment - 8 weeks treatment

Secondary outcomes

  1. UKU-Overall adverse effect scale

    Time frame: Baseline - 4 weeks treatment - 8 weeks treatment

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PACS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2011
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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