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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496690
First Posted: December 21, 2011
Last Update Posted: January 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Albert Einstein College of Medicine, Inc.
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
The Hospital Pharmcacy North Denmark Region, Denmark
Pfizer
Information provided by (Responsible Party):
University of Aarhus
  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.


Condition Intervention Phase
Schizophrenia Anxiety-comorbidity to Schizophrenia Drug: Pregabalin Drug: Pregabalin Placebo Capsules Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Hamilton Anxiety Scale [ Time Frame: Baseline - 4 weeks treatment - 8 weeks treatment ]

Secondary Outcome Measures:
  • UKU-Overall adverse effect scale [ Time Frame: Baseline - 4 weeks treatment - 8 weeks treatment ]

Enrollment: 54
Study Start Date: January 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand name: Lyrica(R)
Placebo Comparator: Pregabalin Placebo Capsules Drug: Pregabalin Placebo Capsules
Parallel to Active Comparator

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496690


Locations
Denmark
Aalborg University Hospital, Psychiatry
Aalborg, Denmark, 9220
Sponsors and Collaborators
University of Aarhus
Albert Einstein College of Medicine, Inc.
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
The Hospital Pharmcacy North Denmark Region, Denmark
Pfizer
Investigators
Principal Investigator: Ole Schjerning, M.D. Aalborg Universitetshospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01496690     History of Changes
Other Study ID Numbers: Eudra CT nr 2010-024488-42
N-20100097 ( Other Identifier: The North Denmark Region Committee on Health Research Ethics )
First Submitted: December 19, 2011
First Posted: December 21, 2011
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by University of Aarhus:
Anxiety-comorbidity to schizophrenia
Double-blinded randomized placebo controlled trial
Pregabalin

Additional relevant MeSH terms:
Schizophrenia
Anxiety Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs