Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

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NCT01496690

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Study Location
Aalborg University Hospital, Psychiatry
Aalborg, , 9220, Denmark
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Anxiety-comorbidity to Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Schizophrenia, Anxiety-comorbidity to SchizophreniaPregablin for Anxiety-comorbidity in Patients With Schizophrenia
NCT01496690
  1. Aalborg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregablin for Anxiety-comorbidity in Patients With Schizophrenia
Official Title  ICMJE Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Anxiety-comorbidity to Schizophrenia
Intervention  ICMJE
  • 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)
  • Drug: Pregabalin Placebo Capsules
    Parallel to Active Comparator
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Pregabalin Placebo Capsules
    Intervention: Drug: Pregabalin Placebo Capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2017)		54
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2011)		70
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01496690
Other Study ID Numbers  ICMJE Eudra CT nr 2010-024488-42
N-20100097 ( Other Identifier: The North Denmark Region Committee on Health Research Ethics )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • Albert Einstein College of Medicine
  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark
  • The Hospital Pharmcacy North Denmark Region, Denmark
  • Pfizer
Investigators  ICMJE
Principal Investigator:Ole Schjerning, M.D.Aalborg University Hospital
PRS Account University of Aarhus
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP