Major Depressive Disorder (MDD)TranscranialNCT07452835
Transcranial Direct Current Stimulation (tDCS) in Different Psychiatric Disorders
A study testing tDCS Parameters in people with Major Depressive Disorder (MDD) and SCHIZOPHRENIA 1 (Disorder), run by Menoufia University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in reducing core symptoms of different psychiatric disorders using validated clinical scales. To assess response and remission rates. To evaluate the durability of treatment effects over follow-up. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD), SCHIZOPHRENIA 1 (Disorder), Obsessive-Compulsive Disorder
- What is being tested?
- tDCS Parameters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 16 and 65 years
- Fulfillment of DSM-5 diagnostic criteria for one of the target disorders
- Stable pharmacological treatment for at least four weeks prior to enrollment (if applicable)
- Ability to provide informed consent
Who cannot join
- History of epilepsy or seizures
- Presence of intracranial metallic implants or implanted electronic devices
- Severe neurological disorders (e.g., brain tumors)
- Pregnancy
- Active substance use disorder
- Severe cognitive impairment or comorbid psychiatric disorders interfering with assessment
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in reducing core symptoms of different psychiatric disorders using validated clinical scales.
- To assess response and remission rates.
- To evaluate the durability of treatment effects over follow-up.
- To examine effects on cognition, daily functioning, and quality of life.
- To monitor tolerability and adverse events.
- Conditions
- Major Depressive Disorder (MDD), SCHIZOPHRENIA 1 (Disorder), Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Insomnia
- Being tested
- tDCS Parameters
- Keywords
- Transcranial direct current stimulation, neuromodulation, psychiatric disorders, major depressive disorder, schizophrenia, obsessive-compulsive disorder, anxiety disorders, insomnia
- Medical subject headings
- Depressive Disorder, Major, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Sleep Initiation and Maintenance Disorders, Mental Disorders, Schizophrenia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS ParametersDevice
Preparation:
- Clean scalp with alcohol to reduce impedance.
- Apply conductive gel and position electrodes using the 10-20 EEG system.
- Use rubber electrodes (5×7 cm) for anodal/cathodal placement.
Stimulation:
Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ).
Post-Stimulation Assessment:
- Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD).
- Repeat sessions 3-5 times per week.. Safety and Monitoring
Adverse Effects:
Mild skin irritation, headache (rarely seizures-screen high-risk patients(.
Contraindications:
Metallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets.
| Study group | Role | What they receive |
|---|---|---|
| A comparative cross-sectional study: Major Depressive Disorder | Experimental | * Left DLPFC (F3) Anode: F3, Cathode: right supraorbital
* 2 mA 20-30 min
* 10 -20 daily ) Receives: Device: tDCS Parameters |
| A comparative cross-sectional study: Schizophrenia | Experimental | * Left TPJ (P3) + Left DLPFC (F3)
* Anode: P3, Cathode: F3 (for hallucinations)
* 2 mA 20 min
* 10-15 Receives: Device: tDCS Parameters |
| A comparative cross-sectional study: Obsessive-Compulsive Disorder | Experimental | * SMA (Cz) or OFC (Fp1/Fp2)
* Anode: Cz/Fp1, Cathode: contralateral shoulder
* 2 mA 20 min
* 10-20 Receives: Device: tDCS Parameters |
| A comparative cross-sectional study ; Generalized Anxiety Disorder | Experimental | * Right DLPFC (F4) or vmPFC
* Anode: F4, Cathode: left DLPFC (F3)
* 2 mA -Session duration: 20-30 minutes per session.
* 10 Receives: Device: tDCS Parameters |
| comparative cross-sectional study; Insomnia | Experimental | * Left DLPFC (F3) or Parietal (Pz)
* Anode: F3/Pz, Cathode: contralateral supraorbital
* 2 mA -Session duration: 20-30 minutes per session.
* 10 -12 Receives: Device: tDCS Parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale
Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale. The total scores on this scale range from a minimum of 0 to a maximum of 60, with higher scores indicating a greater severity of depressive symptoms (a worse outcome)
Measured: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Positive and Negative Syndrome Scale
Symptom severity was evaluated using the Positive and Negative Syndrome Scale. Total scores on this scale range from a minimum of 30 to a maximum of 210, with higher scores indicating a greater severity of symptoms (a worse outcome).
Measured: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Secondary outcomes (3)
Yale-Brown Obsessive Compulsive Scale
The severity of obsessive-compulsive symptoms was measured using the Yale-Brown Obsessive Compulsive Scale. Total scores on this scale range from a minimum of 0 to a maximum of 40, with higher scores indicating more severe symptoms (a worse outcome).
Measured: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Generalized Anxiety Disorder-7
Anxiety severity was measured using the Generalized Anxiety Disorder-7 scale. Total scores on this scale range from a minimum of 0 to a maximum of 21, with higher scores indicating more severe anxiety symptoms (a worse outcome).
Measured: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Insomnia Severity Index - 7 items
The severity of insomnia was assessed using the Insomnia Severity Index. Total scores on this scale range from a minimum of 0 to a maximum of 28, with higher scores indicating more severe insomnia symptoms (a worse outcome).
Measured: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A comparative cross-sectional study including five diagnostic groups: Major Depressive Disorder (MDD), Schizophrenia, Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), and Insomnia
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SSalah el-bahy, Menoufia University
- Investigators
- Mohamed Elbahy, Principal investigator, faculty of medicineMahmoud Abo Salem, Study director, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452835
- Sponsor's protocol ID
- 11/2025 com7
- Acronym
- Transcranial
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification, will be shared with researchers who provide a methodologically sound proposal. The data will be available upon reasonable request to the principal investigator starting 6 months after publication. Requestors will need to sign a data access agreement before data is securely transferred
Publications
Warthen KG, Walker NC, Wicklund BD, Gonzalez MM, Ramirez N, Gee SC, Al-Dasouqi H, Madore MR. Neuromodulation of the Cerebellum for Motor Applications: A Systematic Review. J Integr Neurosci. 2024 Oct 25;23(10):195. doi: 10.31083/j.jin2310195.
PubMed 39473161Hameed MQ, Dhamne SC, Gersner R, Kaye HL, Oberman LM, Pascual-Leone A, Rotenberg A. Transcranial Magnetic and Direct Current Stimulation in Children. Curr Neurol Neurosci Rep. 2017 Feb;17(2):11. doi: 10.1007/s11910-017-0719-0.
PubMed 28229395
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) in Different Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT07452835
- Acronym / sponsor ID
- Transcranial / 11/2025 com7
- Conditions
- Major Depressive Disorder (MDD), SCHIZOPHRENIA 1 (Disorder), Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Insomnia
- Keywords
- Transcranial direct current stimulation, neuromodulation, psychiatric disorders, major depressive disorder, schizophrenia, obsessive-compulsive disorder, anxiety disorders, insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in reducing core symptoms of different psychiatric disorders using validated clinical scales.
- To assess response and remission rates.
- To evaluate the durability of treatment effects over follow-up.
- To examine effects on cognition, daily functioning, and quality of life.
- To monitor tolerability and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- A comparative cross-sectional study including five diagnostic groups: Major Depressive Disorder (MDD), Schizophrenia, Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), and Insomnia
| Arm | Type | Receives |
|---|---|---|
| A comparative cross-sectional study: Major Depressive Disorder | Experimental | Device: tDCS Parameters* Left DLPFC (F3) Anode: F3, Cathode: right supraorbital * 2 mA 20-30 min * 10 -20 daily ) |
| A comparative cross-sectional study: Schizophrenia | Experimental | Device: tDCS Parameters* Left TPJ (P3) + Left DLPFC (F3) * Anode: P3, Cathode: F3 (for hallucinations) * 2 mA 20 min * 10-15 |
| A comparative cross-sectional study: Obsessive-Compulsive Disorder | Experimental | Device: tDCS Parameters* SMA (Cz) or OFC (Fp1/Fp2) * Anode: Cz/Fp1, Cathode: contralateral shoulder * 2 mA 20 min * 10-20 |
| A comparative cross-sectional study ; Generalized Anxiety Disorder | Experimental | Device: tDCS Parameters* Right DLPFC (F4) or vmPFC * Anode: F4, Cathode: left DLPFC (F3) * 2 mA -Session duration: 20-30 minutes per session. * 10 |
| comparative cross-sectional study; Insomnia | Experimental | Device: tDCS Parameters* Left DLPFC (F3) or Parietal (Pz) * Anode: F3/Pz, Cathode: contralateral supraorbital * 2 mA -Session duration: 20-30 minutes per session. * 10 -12 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 16 and 65 years
- Fulfillment of DSM-5 diagnostic criteria for one of the target disorders
- Stable pharmacological treatment for at least four weeks prior to enrollment (if applicable)
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- History of epilepsy or seizures
- Presence of intracranial metallic implants or implanted electronic devices
- Severe neurological disorders (e.g., brain tumors)
- Pregnancy
- Active substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS ParametersPreparation: * Clean scalp with alcohol to reduce impedance. * Apply conductive gel and position electrodes using the 10-20 EEG system. * Use rubber electrodes (5×7 cm) for anodal/cathodal placement. Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment: * Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD). * Repeat sessions 3-5 times per week.. Safety and Monitoring Adverse Effects: Mild skin irritation, headache (rarely seizures-screen high-risk patients(. Contraindications: Metallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets. | Device | A comparative cross-sectional study ; Generalized Anxiety Disorder, A comparative cross-sectional study: Major Depressive Disorder, A comparative cross-sectional study: Obsessive-Compulsive Disorder, A comparative cross-sectional study: Schizophrenia, comparative cross-sectional study; Insomnia |
Primary outcome
Montgomery-Åsberg Depression Rating Scale
Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale. The total scores on this scale range from a minimum of 0 to a maximum of 60, with higher scores indicating a greater severity of depressive symptoms (a worse outcome)
Positive and Negative Syndrome Scale
Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Symptom severity was evaluated using the Positive and Negative Syndrome Scale. Total scores on this scale range from a minimum of 30 to a maximum of 210, with higher scores indicating a greater severity of symptoms (a worse outcome).
3 secondary outcomes
Yale-Brown Obsessive Compulsive Scale
Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Generalized Anxiety Disorder-7
Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Insomnia Severity Index - 7 items
Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 39473161Warthen KG, Walker NC, Wicklund BD, Gonzalez MM, Ramirez N, Gee SC, Al-Dasouqi H, Madore MR. Neuromodulation of the Cerebellum for Motor Applications: A Systematic Review. J Integr Neurosci. 2024 Oct 25;23(10):195. doi: 10.31083/j.jin2310195.
- Background: PubMed 28229395Hameed MQ, Dhamne SC, Gersner R, Kaye HL, Oberman LM, Pascual-Leone A, Rotenberg A. Transcranial Magnetic and Direct Current Stimulation in Children. Curr Neurol Neurosci Rep. 2017 Feb;17(2):11. doi: 10.1007/s11910-017-0719-0.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification, will be shared with researchers who provide a methodologically sound proposal. The data will be available upon reasonable request to the principal investigator starting 6 months after publication. Requestors will need to sign a data access agreement before data is securely transferred
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Elbahy principal investigator
faculty of medicine
Mahmoud Abo Salem study director
faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS Parameters in people with Major Depressive Disorder (MDD) and SCHIZOPHRENIA 1 (Disorder), run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452835, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.