Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia, Anxiety-comorbidity to Schizophrenia

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Pregabalin Placebo Capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pregabalin<br>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. | Drug: Pregabalin<br>* 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.<br>* Other names: Brand name: Lyrica(R);|
| Placebo Comparator: Pregabalin Placebo Capsules<br> | Drug: Pregabalin Placebo Capsules<br>* Parallel to Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Scale |  | Baseline - 4 weeks treatment - 8 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UKU-Overall adverse effect scale |  | Baseline - 4 weeks treatment - 8 weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety-comorbidity to schizophrenia, Double-blinded randomized placebo controlled trial, Pregabalin