Pregabalin for anxiety comorbidity in patients with schizphrenia

Pregabalin for anxiety comorbidity in patients with schizophrenia (PACS) - A Double-blinded Randomized Placebo Controlled Trial - PACS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024488-42-DK

Enrollment

Registered

2011-01-21

Start date

2011-01-31

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

anxiety-comorbidity to schizophrenia MedDRA version: 19.0 Level: LLT Classification code 10013387 Term: Disorganized type schizophrenia System Organ Class: 100000004873 MedDRA version: 19.0 Level: LLT Classification code 10013386 Term: Disorganised schizophrenia System Organ Class: 100000004873 MedDRA version: 19.0 Level: LLT Classification code 10007780 Term: Catatonic schizophrenia System Organ Class: 100000004873 MedDRA version: 19.0 Level: LLT Classification code 10019364 Term: Hebephren

Interventions

Trade Name: Lyrica® 75 mg Product Name: Pregabalin Product Code: EU/1/04/279/001-043 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pregabalin CAS Number: 148553-50-8 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 18-65 years 2) An ICD-10 schizophrenia diagnosis F20.0-F20.3 or F20.9 3) Fixed dose of psychotropics during the last 4 weeks before inclusion 4) Hamilton Anxiety scale total score > 15 5) Positive and Negative Syndrome Scale total score =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Significant substance abuse 2) QTc>480 ms 3) Severe dysregulated diabetes 4) For women: pregnancy or breast-feeding 5) Retainment due to the mental health act. 6) Concrete suicidalplans 7) Known allergic to the trial drug

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety. ;Secondary Objective: -;Primary end point(s): Hamilton Anxiety Scale The UKU side effect rating scale;Timepoint(s) of evaluation of this end point: Baseline, after 4 and 8 weeks	—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Baseline, after 4 og 8 weeks;Secondary end point(s): PANSS, CGI WHO-Qol LSEQ PSP Sedation VAS BACS	—

Countries

Denmark

Contacts

Public ContactCentre for Psychosis Research

Aalborg University Hospital, Aalborg Psychiatric Hospital

o.schjerning@rn.dk004597643562

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026