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Treatment of Auditory Hallucinations in Schizophrenia With Bilateral Theta Burst Stimulation

NCT02670291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-03-25

No results posted yet for this study

Summary

This randomized, sham-controlled, double blind, multicentre clinical trial aims at providing evidence for the efficacy and safety of continuous theta burst stimulation (cTBS) in the treatment of auditory hallucinations in patients with schizophrenia. Overall, the study will include 137 patients. Because of the adaptive study design, an interim analysis was performed after half of the originally planned patients (43/86), according to which the sample size was increased by 51 patients). Each patient will receive a three weeks course of daily (5/week) treatment; 50% of the patients will be treated with cTBS (1200 impulses daily), the other half with a sham stimulation to the left and right temporoparietal cortex. Sham stimulation will be applied by an active sham-coil that allows for a double-blind treatment. Follow-up assessments 1, 3 and 6 months after treatment will investigate the stability of treatment effects.

Conditions

Interventions

DEVICE

MagPro Cool-B65A/P, Magventure

combined active and sham coil

DEVICE

MagPro Cool-B65A/P, Magventure

combined active and sham coil

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Institute for Clinical Epidemiology and Applied Biometry, University Tuebingen, Germany

    collaborator UNKNOWN

  • Center for Clinical Studies, University Tuebingen (ZKS), Germany

    collaborator UNKNOWN

  • Department of Psychiatry and Psychotherapy, University Munich (LMU), Germany

    collaborator UNKNOWN

  • University of Ulm

    collaborator OTHER

  • Department of Psychiatry and Psychotherapy; University Heidelberg, Germany

    collaborator UNKNOWN

  • Department of Psychiatry and Psychotherapy; Unversity Augsburg, Germany

    collaborator UNKNOWN

  • Department of Psychiatry and Psychotherapy, LVR Duesseldorf, Germany

    collaborator UNKNOWN

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Christian Plewnia, Prof. MD. · Dept. Psychiatry and Psychotherapy, Universtiy of Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2023-11-30
Completion
2024-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02670291 on ClinicalTrials.gov