Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

Phase 4

Completed

• Conditions: Anxiety-comorbidity to Schizophrenia; Schizophrenia
• Interventions: Drug: Pregabalin; Drug: Pregabalin Placebo Capsules

• Registration Number: NCT01496690
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-21
• Study Start: 2012-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregabalin	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.
Pregabalin Placebo Capsules	Pregabalin Placebo Capsules	-

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Scale	Baseline - 4 weeks treatment - 8 weeks treatment

Secondary Outcome Measures

Name	Time	Method
UKU-Overall adverse effect scale	Baseline - 4 weeks treatment - 8 weeks treatment

Trial Locations

Locations (1)

Aalborg University Hospital, Psychiatry; 🇩🇰 Aalborg, Denmark