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

Primary Purpose

Schizophrenia, Anxiety-comorbidity to Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Pregabalin
Pregabalin Placebo Capsules
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Anxiety-comorbidity to schizophrenia, Double-blinded randomized placebo controlled trial, Pregabalin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg University Hospital, Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

pregabalin

Pregabalin Placebo Capsules

Arm Description

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.

Outcomes

Primary Outcome Measures

Hamilton Anxiety Scale

Secondary Outcome Measures

UKU-Overall adverse effect scale

Full Information

First Posted
December 19, 2011
Last Updated
January 6, 2017
Sponsor
University of Aarhus
Collaborators
Albert Einstein College of Medicine, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, The Hospital Pharmcacy North Denmark Region, Denmark, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01496690
Brief Title
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia
Acronym
PACS
Official Title
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Albert Einstein College of Medicine, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, The Hospital Pharmcacy North Denmark Region, Denmark, Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Anxiety-comorbidity to Schizophrenia
Keywords
Anxiety-comorbidity to schizophrenia, Double-blinded randomized placebo controlled trial, Pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregabalin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pregabalin Placebo Capsules
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Brand name: Lyrica(R)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin Placebo Capsules
Intervention Description
Parallel to Active Comparator
Primary Outcome Measure Information:
Title
Hamilton Anxiety Scale
Time Frame
Baseline - 4 weeks treatment - 8 weeks treatment
Secondary Outcome Measure Information:
Title
UKU-Overall adverse effect scale
Time Frame
Baseline - 4 weeks treatment - 8 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Schjerning, M.D.
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital, Psychiatry
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

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Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

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