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

This study is currently recruiting participants.
Verified April 2013 by University of Aarhus
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
The Hospital Pharmcacy North Denmark Region, Denmark
Pfizer
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01496690
First received: December 19, 2011
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Hamilton Anxiety Scale [ Time Frame: Baseline - 4 weeks treatment - 8 weeks treatment ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 70
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496690

Locations
Denmark
Aalborg University Hospital, Aalborg Psychiatric Hospital, Centre for Schizophrenia Recruiting
Aalborg, Denmark, 9220
Contact: Jimmi Nielsen, M.D     +4572137233     jin@rn.dk    
Contact: Dorrit Thode     +4572137836     dwt@rn.dk    
Principal Investigator: Jimmi Nielsen, M.D.            
Sponsors and Collaborators
University of Aarhus
Albert Einstein College of Medicine of Yeshiva University
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
The Hospital Pharmcacy North Denmark Region, Denmark
Pfizer
Investigators
Principal Investigator: Jimmi Nielsen, M.D. Aalborg University Hospital, Aalborg Psychiatric Hospital, Centre for Schizophrenia
Principal Investigator: Ole Schjerning, M.D. Aalborg University Hospital, Aalborg Psychiatric Hospital, Centre for Schizophrenia
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01496690     History of Changes
Other Study ID Numbers: Eudra CT nr 2010-024488-42, J.nr. N20100097
Study First Received: December 19, 2011
Last Updated: April 12, 2013
Health Authority: Denmark: Danish Health and Medicines Authority, Consumer Safety, Clinical Trials
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency, The North Denmark Region
Denmark: GCP-unit at Aarhus University Hospital, Aarhus

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

Additional relevant MeSH terms:
Anxiety Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Pregabalin
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on June 17, 2013