rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Negative Symptoms With Primary Psychotic Disorder
- Sponsor
- University of Regensburg
- Enrollment
- 90
- Locations
- 4
- Primary Endpoint
- Scale for the Assessement of Negative Symptoms (SANS)
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
Treatment of depression with repetitive transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. The treatment of negative symptoms with the same protocol in schizophrenia is considered as possible effective. Theta burst stimulation is a new protocol which is characterized by shorter sessions showing first evidence that it's efficacy is comparable to the high-frequency rTMS. In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated.
Detailed Description
In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated. The active study arms are high-frequency rTMS and iTBS of the left dorsolateral prefrontal cortex to treat negative symptoms in schizophrenia. The control arm will include the same number of patients as each active arm and includes both sham rTMS and sham iTBS in the same proportion as the active treatments. Standards of the trial will be harmonized across four clinical centers with the aim to pool data for analysis. Each center is responsible for ethical approval and adherence to good clinical practice by itself (Sponsor). Interim analysis: Several meta-analyses of the effect of rTMS/iTBS on negative symptoms in schizophrenia showing heterogeneous effect sizes have been published since begin of the trial. Thefore, we added an interim analysis after inclusion of at least 15 patients in each arm to the protocol. In case of null findings and low effect sizes (no differences of either rTMS or TBS vs. sham in the primary outcome), we would terminate the trial.
Investigators
Berthold Langguth, MD, Ph.D.
Clinical Professor
University of Regensburg
Eligibility Criteria
Inclusion Criteria
- •ICD-10: schizophrenia with primarily negative symptoms
- •Age: 18-75 years
- •at least 35 Points at the composite score of the SANS
- •stabe medication during the last 2 weeks (at the investigator's discretion)
- •written informed consent (by the patient or guardian)
Exclusion Criteria
- •clinically relevant unstable concomitant somatic diseases
- •previous treatment by rTMS
- •conditions in which TMS may not be applicated, as e.g., cardiac pacemakers or ferromagnetic implants
- •history of epileptic seizures
- •current substance or alcohol abuse, or clinically relevant comorbidity (according to M.I.N.I. interview)
- •unacceptable concomitant medication (benzodiazepines in higher doses, e.g., Lorazepam \> 2 mg/d, Diazepam \> 10 mg/d)
- •insufficient knowledge of the language of the country of the treatment site
- •pregnancy and nursing period
- •current statutory hospitalisation
Outcomes
Primary Outcomes
Scale for the Assessement of Negative Symptoms (SANS)
Time Frame: 4 weeks
negative symptoms in schizophrenia with 25 items and a range 0-125 with higher score representing more symptoms
Secondary Outcomes
- Memory span test (digit span)(4 weeks, 12 weeks)
- cigarettes(4 weeks, 12 weeks)
- Calgary Depression Scale for Schizophrenia (CDSS)(2 weeks, 4 weeks, 12 weeks)
- Resting state electroencephalogram (EEG)(4 weeks)
- Positive and Negative syndrome scale (PANSS)(2 weeks, 4 weeks, 12 weeks)
- test of attention (d2)(4 weeks, 12 weeks)
- Major Depression Inventory (MDI)(2 weeks, 4 weeks, 12 weeks)
- Hamilton depression rating scale (HDRS)(2 weeks, 4 weeks, 12 weeks)
- Scale for the Assessement of Negative Symptoms (SANS)(2 weeks, 4 weeks, 12 weeks)
- Clinical global impression (CGI)(2 weeks, 4 weeks, 12 weeks)
- magnetic resonance imaging (MRI)(4 weeks)