Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01496690

Acronym

PACS

Enrollment

Registered

2011-12-21

Start date

2012-01-31

Completion date

2016-12-31

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety-comorbidity to Schizophrenia, Schizophrenia

Keywords

Anxiety-comorbidity to schizophrenia, Double-blinded randomized placebo controlled trial, Pregabalin

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.

Interventions

DRUGPregabalin

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.

DRUGPregabalin Placebo Capsules

Parallel to Active Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Hamilton Anxiety Scale	Baseline - 4 weeks treatment - 8 weeks treatment

Secondary

Measure	Time frame
UKU-Overall adverse effect scale	Baseline - 4 weeks treatment - 8 weeks treatment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026