Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

NCT ID: NCT01496690

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Schizophrenia; Anxiety-comorbidity to Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: 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.

Pregabalin Placebo Capsules

Group Type: PLACEBO_COMPARATOR

Pregabalin Placebo Capsules

Intervention Type: DRUG

Parallel to Active Comparator

Interventions

Pregabalin

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.

Intervention Type: DRUG

Pregabalin Placebo Capsules

Parallel to Active Comparator

Intervention Type: DRUG

Other Intervention Names

Brand name: Lyrica(R)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

GCP-unit at Aarhus University Hospital, Aarhus, Denmark

OTHER

Sponsor Role: collaborator

The Hospital Pharmcacy North Denmark Region, Denmark

UNKNOWN

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ole Schjerning, M.D.

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Aalborg University Hospital, Psychiatry

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

N-20100097

Identifier Type: OTHER

Identifier Source: secondary_id

Eudra CT nr 2010-024488-42

Identifier Type: -

Identifier Source: org_study_id