Pregablin for Anxiety-comorbidity in Patients With Schizophrenia (PACS)
|ClinicalTrials.gov Identifier: NCT01496690|
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : January 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Anxiety-comorbidity to Schizophrenia||Drug: Pregabalin Drug: Pregabalin Placebo Capsules||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: 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.
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.
Other Name: Brand name: Lyrica(R)
|Placebo Comparator: Pregabalin Placebo Capsules||
Drug: Pregabalin Placebo Capsules
Parallel to Active Comparator
- Hamilton Anxiety Scale [ Time Frame: Baseline - 4 weeks treatment - 8 weeks treatment ]
- UKU-Overall adverse effect scale [ Time Frame: Baseline - 4 weeks treatment - 8 weeks treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496690
|Aalborg University Hospital, Psychiatry|
|Aalborg, Denmark, 9220|
|Principal Investigator:||Ole Schjerning, M.D.||Aalborg Universitetshospital|