Pregablin for Anxiety-comorbidity in Patients With Schizophrenia (PACS)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 University Hospital|