Pregablin for Anxiety-comorbidity in Patients With Schizophrenia
NCT01496690
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Pregablin for Anxiety-comorbidity in Patients With Schizophrenia | |||
Official Title ICMJE | Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 54 | |||
Original Estimated Enrollment ICMJE | 70 | |||
Actual Study Completion Date ICMJE | December 2016 | |||
Actual Primary Completion Date | December 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01496690 | |||
Other Study ID Numbers ICMJE | Eudra CT nr 2010-024488-42 N-20100097 ( Other Identifier: The North Denmark Region Committee on Health Research Ethics ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Aarhus | |||
Study Sponsor ICMJE | University of Aarhus | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Aarhus | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |