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NCT Number: NCT03468686

The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder

Rumination is significantly frequent in major depressive disorder. However, not a lot of studies have investigated the effects of repetitive transcranial magnetic stimulation on rumination and its electrophysiological correlates. This study recruited 61 participants who were randomly assigned to sham, bilateral, or unilateral stimulation groups to investigate the potential differences between these stimulation protocols and changes in the behavioral and electrophysiological outcomes after treatment.

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Key information

Conditions

Major Depressive Disorder Anhedonia Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rumination Syndrome Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atieh Clinical Neuroscience Center (ACNC)

Tehran, 1969713663, Iran

About this study

This study aims to compare the effect of unilateral and bilateral rTMS on the reduction of rumination and anhedonia and their associated neural networks. In a randomized double-blind trial, 65 patients with depressive disorder in Atieh Clinical Neuroscience Center are assigned to three groups. The first group receives bilateral rTMS for 20 sessions on right and left DLPFC; the second group receives unilateral rTMS for 20 sessions on LDLPFC; third group receives sham rTMS for 10 sessions. In this group, the stimulation parameters are similar to that in the actual rTMS group, except that the coil angel is 90° and perpendicular to the head. Rumination and anhedonia symptoms will be measured by the Ruminative Responses Scale (RRS) and Snaith-Hamilton Pleasure Scale (SHAPS) in the baseline and after the 20th session. In order to investigate the neural networks associated with rumination and anhedonia, EEG of patients will be recorded at the first session and at the end of the treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients male and female with the range of 18-65 years of age
  • The diagnosis of Major depressive disorder according to DSM-V
  • Having BDI>18
  • Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks
  • Completion of consent form
  • Being under supervision of a psychiatrist

Exclusion criteria

  • The history of rTMS treatment for any reason
  • Cardiac pacemaker
  • The risk of seizure with any reasons
  • Pregnancy
  • High risk of suicide
  • Intracranial implant and other ferromagnetic materials close to the head

Treatment and study plan

Bilateral rTMS

Device

The coil will locate on F3 and F4 in accordance with the 10-20 international system. bilateral rTMS include stimulate the right DLPFC at 1 Hz for a 10 seconds train of stimulation, and a total of 150 pulse trains. Immediately after that, the stimulation was carried out on the left DLPFC at 10 Hz, 5 seconds of stimulation, with 10 second inter-train interval and 75 pulse trains.

sham rTMS

Device

The same parameters will use in the sham rTMS. However, the coil adjust at an angle of 90º vertically on the skull in a way that one wing place on the head.

Unilateral rTMS (High frequency)

Device

The coil will locate on F3 in accordance with the 10-20 international system. Unilateral rTMS include stimulate the Left DLPFC at 10Hz for a 5seconds train of stimulation, 10 seconds inter-train interval, and a total of 75 pulse trains. .

Primary outcomes

  1. Rumination Symptoms

    Time frame: baseline before start of treatment and immediately after the last treatment session.

    The Ruminative Responses Scale (RRS) is a measure of depressive rumination which has two subscales: Both subscales are composed of five items. Brooding and Reflection. Higher score indicate a higher level of ruminative responses (range: 22-88).

  2. changes in default mode network

    Time frame: baseline before start of treatment and immediately after the last treatment session.

    EEG

  3. Anhedonia Symptoms

    Time frame: baseline before start of treatment and immediately after the last treatment session.

    Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia

Secondary outcomes

  1. Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale

    Time frame: baseline before start of treatment and immediately after the last treatment session.

    Hamilton Depression Rating Scale (HDRS),(HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22

  2. Depressive symptoms measured by the 21-item Beck Depression Inventory-II

    Time frame: baseline before start of treatment and immediately after the last treatment session.

    Beck Depression Inventory-II (BDI-II), (BDI-II) Range: 0-63 Normal: 0-13 Mild: 14- 9 Moderate 20- 28 Severe: 29-63

Sponsors and collaborators

Lead sponsor

University of Tehran

Other

Collaborators

  • Stanford University

Registry information

Official study title

The Study of Effectiveness of Unilateral and Bilateral Repetitive Transcranial Magnetic Stimulation (rTMS) on Rumination and Anhedonia in Patients With Major Depressive Disorder

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2018
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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