NCT01496690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

4.9 years

First QC Date

December 19, 2011

Last Update Submit

January 6, 2017

Conditions

SchizophreniaAnxiety-comorbidity to Schizophrenia

Keywords

Anxiety-comorbidity to schizophreniaDouble-blinded randomized placebo controlled trialPregabalin

Outcome Measures

Primary Outcomes (1)

  • Hamilton Anxiety Scale

    Baseline - 4 weeks treatment - 8 weeks treatment

Secondary Outcomes (1)

  • UKU-Overall adverse effect scale

    Baseline - 4 weeks treatment - 8 weeks treatment

Study Arms (2)

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.

Drug: Pregabalin

Pregabalin Placebo Capsules

PLACEBO COMPARATOR
Drug: Pregabalin Placebo Capsules

Interventions

PregabalinDRUG

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.

Also known as: Brand name: Lyrica(R)
pregabalin
Pregabalin Placebo CapsulesDRUG

Parallel to Active Comparator

Pregabalin Placebo Capsules

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-65 years
  • An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital, Psychiatry

Aalborg, 9220, Denmark

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Ole Schjerning, M.D.

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

DK(1)