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

Primary Purpose

Mood Disorders

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
TMS
Sponsored by
Sveti Ivan Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PB Sveti Ivan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TMS

noTMS

Arm Description

The experimental group will be treated with transcranial magnetic stimulation for 4 weeks.

The control (no intervention) group will be treated as usual (with pharmacotherapy). These patients will receive TMS treatment after data collection is ended.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2016
Last Updated
June 23, 2019
Sponsor
Sveti Ivan Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02917499
Brief Title
Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sveti Ivan Psychiatric Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS
Arm Type
Experimental
Arm Description
The experimental group will be treated with transcranial magnetic stimulation for 4 weeks.
Arm Title
noTMS
Arm Type
No Intervention
Arm Description
The control (no intervention) group will be treated as usual (with pharmacotherapy). These patients will receive TMS treatment after data collection is ended.
Intervention Type
Device
Intervention Name(s)
TMS
Intervention Description
Transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
the proportion of patients who experienced complete remission of the disease
Description
Measurement points: immediately after the end of treatment, and follow-up after 3 and 6 months.
Time Frame
up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
PB Sveti Ivan
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Citations:
PubMed Identifier
31059991
Citation
Filipcic I, Simunovic Filipcic I, Milovac Z, Sucic S, Gajsak T, Ivezic E, Basic S, Bajic Z, Heilig M. Efficacy of repetitive transcranial magnetic stimulation using a figure-8-coil or an H1-Coil in treatment of major depressive disorder; A randomized clinical trial. J Psychiatr Res. 2019 Jul;114:113-119. doi: 10.1016/j.jpsychires.2019.04.020. Epub 2019 Apr 26.
Results Reference
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Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders

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