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Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

NCT01496690 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-01-09

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Pregabalin Placebo Capsules

Parallel to Active Comparator

Sponsors & Collaborators

  • Albert Einstein College of Medicine

    collaborator OTHER

  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark

    collaborator OTHER

  • The Hospital Pharmcacy North Denmark Region, Denmark

    collaborator UNKNOWN

  • Pfizer

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Ole Schjerning, M.D. · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01496690 on ClinicalTrials.gov