Accelerated intermittent Theta Burst Stimulation (aiTBS) in bipolar disorder and schizophrenia

Recruiting

Conditions: Bipolar disorder and schizophrenia
10039628

Registration Number: NL-OMON53634

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

- 18-65 years
- Ability to freely written informed consent
- DSM-5 diagnosis of current depressive episode in bipolar I or II disorder OR
DSM-5 diagnosis of schizophrenia
- Therapy resistanve in bipolar disorder
- HDRS>16 in bipolar depression at start study
- SANS>3 on each item in schziphrenia
- Stable medication (antidepressants or antipsychotics) at least 4 weeks prior
start study.

Exclusion Criteria

* In BPD, (hypo) manic episode within 3 months prior start of the trial;
* In BPD, Young Mania Rating Scale (YMRS) score of >12 prior start of the trial;
* Patients with bipolar II disorder who use anti-depressant medication without
anti-manic medication or patients with bipolar I disorder, not using anti-manic
medication;
* Acute suicidality;
* (History of) neurological disease
* (History of) epilepsy or epilepsy in a 1st degree relative;
* Pregnancy;
* Disorder in substance abuse
* Known serious somatic health problem;
* Used recreational drugs over a period of 72 hours prior each session;
* Used alcohol within the last 24 hours prior each session;
* Specific TMS contraindications (see standard screening form, appendix 1):
ICD, pacemaker, history of epileptic seizures of epilepsy in a 1st degree
relative, intracranial metal implants(e.g. cochlear implant or deep brain
stimulator).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes are response (defined by 50% reduction on the HDRS, QIDS-SR ,<br /><br>PANSS, SANS and CDSS), remission (defined by HDRS <7, QIDS-SR <5, all items on<br /><br>the negative scale PANSS <3, SANS <3, CDSS<6) and feasibility and tolerability<br /><br>measured by side-effects and drop-out rates. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess Heart Rate Variability (HRV) as part of parasympatic activation<br /><br>through dlPFC stimulation. HRV is measured through electrocardiogram (ECG).</p><br>