Pregablin for Anxiety-comorbidity in Patients With Schizophrenia (PACS)

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Anxiety-comorbidity to Schizophrenia

Treatments: Drug: Pregabalin Placebo Capsules; Drug: Pregabalin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01496690

N-20100097 (Other Identifier)

Eudra CT nr 2010-024488-42

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

pregabalin

Active Comparator group

Description:

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.

Treatment:

Drug: Pregabalin

Pregabalin Placebo Capsules

Placebo Comparator group

Treatment:

Drug: Pregabalin Placebo Capsules