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| ID | Type | Description | Link |
|---|---|---|---|
| N-20100097 | Other Identifier | The North Denmark Region Committee on Health Research Ethics |
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| Name | Class |
|---|---|
| Albert Einstein College of Medicine | OTHER |
| GCP-unit at Aarhus University Hospital, Aarhus, Denmark | OTHER |
| The Hospital Pharmcacy North Denmark Region, Denmark | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Active Comparator | 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. |
|
| Pregabalin Placebo Capsules | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Scale | Baseline - 4 weeks treatment - 8 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| UKU-Overall adverse effect scale | Baseline - 4 weeks treatment - 8 weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole Schjerning, M.D. | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital, Psychiatry | Aalborg | 9220 | Denmark |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Pfizer |
| INDUSTRY |
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| Pregabalin Placebo Capsules | Drug | Parallel to Active Comparator |
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |