Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

Schizophrenia Clinical Trial

— PACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496690
• Other study ID #: Eudra CT nr 2010-024488-42
• Secondary ID: N-20100097
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2011
• Last updated: January 6, 2017
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority, Consumer Safety, Clinical TrialsDenmark: The North Denmark Region Committee on Health Research EthicsDenmark: Danish Dataprotection Agency, The North Denmark RegionDenmark: GCP-unit at Aarhus University Hospital, Aarhus
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety-comorbidity to Schizophrenia
• Schizophrenia

Intervention

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.
• Pregabalin Placebo Capsules
Parallel to Active Comparator

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital, Psychiatry	Aalborg

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Albert Einstein College of Medicine of Yeshiva University, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Pfizer, The Hospital Pharmcacy North Denmark Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Scale		Baseline - 4 weeks treatment - 8 weeks treatment	No
Secondary	UKU-Overall adverse effect scale		Baseline - 4 weeks treatment - 8 weeks treatment	Yes