Status:
COMPLETED
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Albert Einstein College of Medicine
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Conditions:
Schizophrenia
Anxiety-comorbidity to Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01496690
Start Date
January 1 2012
End Date
December 1 2016
Last Update
January 9 2017
Active Locations (1)
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1
Aalborg University Hospital, Psychiatry
Aalborg, Denmark, 9220