NCT02670291Completed
Treatment of Auditory Hallucinations in Schizophrenia With Bilateral Theta Burst Stimulation
Source: ClinicalTrials.gov · Last updated 25 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 138 (actual)
- First submitted
- 26 Jan 2016
- Start date
- 1 Jan 2017
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Schizophrenia
- NCT number
- NCT02670291
What you commit to
- Study type: Interventional
- Participants enrolled: 138
- From 1 Jan 2017 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History/evidence of brain surgery
Other illness
- Neurodegenerative disorder
- History of seizures
- Cardiac pacemakers
Other
- Suicidality
- Significant brain malformation or neoplasm
- Head injury
- Cerebral vascular events
- Deep brain stimulation
- Intracranial metallic particles
- Diagnose of substance dependence or abuse as primary clinical problem
- Severe somatic comorbidity
- Pregnancy
Who the study is looking for
- Men and women, age 18-65 years
- Schizophrenia (DSM-5 295.90), schizophreniform disorder (DSM-5, 295.40), or schizoaffective disorder (DSM-5 295.70)
- Auditory hallucinations (AH) present at least once a week, for at least 3 months
- No sufficient effect of at least one adequate antipsychotic treatment
- Severity according to PANSS hallucination score (Item P3) of 3 or more
- Fluent German language
- Stable antipsychotic medication 2 weeks before and 3 weeks during the treatment
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.