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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01496690
First received: December 19, 2011
Last updated: January 6, 2017
Last verified: January 2017
  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: 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:


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 19, 2011
Last Updated: January 6, 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

ClinicalTrials.gov processed this record on February 20, 2017