Schizophrenia Clinical Trial
— PACSOfficial title:
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital, Psychiatry | Aalborg |
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 |
Denmark,
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 |
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