NCT06775054Completed
Cognitive Flexibility in Depression and TMS Response
The Role of Cognitive Flexibility in Depression and Response to Transcranial Magnetic Stimulation (TMS)
Source: ClinicalTrials.gov · Last updated 14 Jan 2025
Brief summary (registry, in English)
The primary aim of this study is to determine the level of cognitive flexibility in patients with TRD before treatment and to explore whether there is a relationship with their response to TMS treatment. More specifically, the study aims to identify the role of cognitive flexibility as a neurocognitive marker that could predict whether patients planned to undergo TMS treatment will respond to the treatment. The main focus of this study is to ascertain whether the data obtained have practical implications, particularly regarding the identification of TRD patients who do not respond to TMS treatment in advance.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 29 Dec 2024
- Start date
- 15 Mar 2023
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- Gulhane Training and Research Hospital
- Diseases
- Depression
- NCT number
- NCT06775054
What you commit to
- Study type: Interventional
- Participants enrolled: 49
- From 15 Mar 2023 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous head trauma, loss of consciousness and intra-cerebral surgery,
- The patient has previously had a psychotic attack or bipolar mood attack,
- The patient has previously had a substance-induced psychosis or bipolar mood disorder,
- The patient has previously used substances known as alcohol, drugs or stimulants according to DSM-V TR and semi-structured clinical interview (SCID-5 TR) have abuse or addiction (except if they have not used in the last 12 months or have not abused alcohol),
Other illness
- A significant disorder in the thyroid hormone profile in routine blood checks before TMS,
- A vitamin deficiency that may cause cognitive impairment or forgetfulness in routine blood checks before TMS,
Other
- According to the pre-TMS risk assessment form, there is a contraindication for treatment,
- Epileptic focus is detected in the pre-TMS electroencephalography findings,
- A metal particle caused by an aneurysm clip, connection tongs or explosive substances that will affect the electromagnetic field in the brain,
- A significant increase in inflammation markers in routine checks before TMS,
- A presence of electrolyte imbalance in routine blood checks before TMS,
- Those who want to terminate TMS treatment voluntarily, Note:If an unexpected clinical situation occurs during TMS treatment, the patient will be excluded from the study.
Who the study is looking for
- Diagnosed with Major Depressive Disorder according to DSM-5 TR.
- Diagnosed with Obsessive-Compulsive Disorder according to DSM-5 TR.
- Lack of response to treatment after being administered at least two different antidepressants and anti-obsessive agents at effective doses and durations.
- The clinical condition cannot be better explained by a metabolic or organic disorder.
- Routine electroencephalography (EEG) findings before TMS do not indicate electrical activity consistent with an epileptic focus.
- Routine blood tests before TMS show no conditions that could affect treatment levels, particularly thyroid issues, vitamin deficiencies, or inflammation parameters that might cause depression or cognitive impairment (consultation with relevant departments if necessary).
- No history of hearing loss identified during routine evaluations (if a history of hearing loss exists, consultation will be requested; if none, the process will proceed accordingly).
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gulhane Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.