Pregabalin for anxiety comorbidity in patients with schizphrenia

Phase 1

Active, not recruiting

• Conditions: anxiety-comorbidity to schizophrenia; MedDRA version: 19.0Level: LLTClassification code 10013387Term: Disorganized type schizophreniaSystem Organ Class: 100000004873; MedDRA version: 19.0Level: LLTClassification code 10033872Term: Paranoid schizophreniaSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]; MedDRA version: 19.0Level: LLTClassification code 10013386Term: Disorganised schizophreniaSystem Organ Class: 100000004873; MedDRA version: 19.0Level: LLTClassification code 10007780Term: Catatonic schizophreniaSystem Organ Class: 100000004873; MedDRA version: 19.0Level: LLTClassification code 10019364Term: Hebephrenic schizophreniaSystem Organ Class: 100000004873

• Registration Number: EUCTR2010-024488-42-DK
• Lead Sponsor: Aalborg University Hospital, Aalborg Psychiatric Hospital, Centre for Psychosisresearch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-21
• Study Completion: 2016-08-15
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 54

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 < 70
6) The Calagary Depression Scale for Schizophrenia total score < 10
7) For fertile women: Preganancy test negative and sexual abstinence or birth control methods during the study.
8) S-creatinin within normal reference range.
9) Signed informed constent and power attorney
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Baseline, after 4 og 8 weeks;Secondary end point(s): PANSS, CGI<br>WHO-Qol<br>LSEQ<br>PSP<br>Sedation VAS<br>BACS