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NCT02917499 Clinical Trial

Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders

Mood Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02917499
Other study ID # TMS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date December 2018

Study information
Verified date June 2019
Source Sveti Ivan Psychiatric Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to examine the efficacy and safety of transcranial magnetic stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and neurological disorders. Subjects will be randomized into two groups: experimental (treated with pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They and their clinicians will complete a battery of instruments that measure relevant symptoms, global functioning and quality of life. The first measurement will be done after the inclusion and before treatment. The second measurement will be made immediately after the end of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3 and 6 months.

Recruitment information / eligibility
Status Completed
Enrollment 228
Est. completion date December 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- diagnosed psychiatric or neurological disorder, duration of disorder for at least 5 years, inpatients or outpatients treated in Psychiatric hospital Sveti Ivan

Exclusion Criteria:

- suicidality, psychosis, alcohol addiction, unable to complete the questionnaires

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TMS
Transcranial magnetic stimulation

Locations
Country Name City State
Croatia PB Sveti Ivan Zagreb

Sponsors (1)
Lead Sponsor Collaborator
Sveti Ivan Psychiatric Hospital

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary the proportion of patients who experienced complete remission of the disease Measurement points: immediately after the end of treatment, and follow-up after 3 and 6 months. up to six months
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