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

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ClinicalTrials.gov Identifier: NCT01496690
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : January 9, 2017
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

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Anxiety-comorbidity to Schizophrenia Drug: Pregabalin Drug: Pregabalin Placebo Capsules Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

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 Posted: December 21, 2011    Key Record Dates
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