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Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study

NCT01496690•University of Aarhus

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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

Locations (1)

Aalborg University Hospital, Psychiatry

Aalborg, Denmark

Key Dates

Start Date

January 1, 2012

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

January 9, 2017

Enrollment

ACTUAL participants

Conditions

SchizophreniaAnxiety-comorbidity to Schizophrenia

Interventions

Pregabalin

DRUG

Pregabalin Placebo Capsules

DRUG

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NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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