Obsessive-Compulsive DisorderNCT05563935
Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder
A study testing Repetitive transcranial magnetic stimulation in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study, a case-control study, aims to investigate the function-metabolism coupling in decision-making confidence neural network of obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Dec 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- OCD group:
- Age between 18 and 50 years.
- Satisfied with the diagnostic criteria for OCD in DSM-V.
- Taking medication or unmedication stably for 8 weeks or drug-naive.
- YBOCS score ≥16.
- Education level was limited to above middle school.
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- Has sufficient audiovisual skills to complete the necessary examinations for the study.
- Right-handed (this criterion is for fMRI subjects only).
- Subjects understood the study and signed informed consent.
- HC group:
- Match with the OCD group on age, gender, education years.
- Unsatisfied with the diagnostic criteria for any mental disorder in DSM-V.
- No history of taking psychotropic drugs.
- No family genetic history of mental disorder.
- Has sufficient audiovisual skills to complete the necessary examinations for the study.
- Right-handed (this criterion is for fMRI subjects only).
- Subjects understood the study and signed informed consent.
Who cannot join
- OCD group:
- Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
- HAMD-17 score ≥ 17.
- IQ < 70.
- Obsessive-compulsive symptoms were too severe to participate in the experiment.
- Hoarding symptom.
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- High risk of negative thought and suicide.
- Severe central system or physical disease or drug abuse.
- Pregnant women or women that getting ready for being pregnant and lactating.
- With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)
- HC group:
- High risk of negative thought and suicide.
- HAMD-17 score ≥ 17.
- IQ < 70.
- Severe central system or physical disease or drug abuse.
- Pregnant women or women that getting ready for being pregnant and lactating.
- With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Study of Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder
This study, a case-control study, aims to investigate the function-metabolism coupling in decision-making confidence neural network of obsessive-compulsive disorder.
Read the detailed description
OCD shows various abnormalities in cognitive function. Decision-making confidence is a burgeoning research focus on cognitive abnormality of OCD. Gamma-aminobutyric acid (GABA) is a type of inhibitory amino acid. Some studies have indicated that GABA shows metabolic abnormality in OCD.
Repetitive transcranial magnetic stimulation (rTMS) is a safe and noninvasive treatment for OCD. This study intends to explore the differences of the function-metabolism coupling in decision-making confidence neural network between OCD and HC. And investigating the dynamic changes of the function-metabolism coupling after rTMS treatment (6 weeks) for OCD is another goal.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- Obsessive-Compulsive Disorder, Case-control study, Repetitive transcranial magnetic stimulation, Decision-making confidence, Metabolism, Neural network, GABA
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
The OCD group will receive rTMS treatment for 6 weeks. There are 5 rTMS treatments per week (Monday to Friday), and 30 rTMS treatments in total. Treatment is administered by Ma GPro X100 device (Maga Venture) with Cool-DB80 coil. Detailed parameters of rTMS: intensity of stimulus is 120% RMT; the frequency of trains is 1Hz and the number of pulses is 1; no intertrain intervals and the pulses number is 1000.
| Study group | Role | What they receive |
|---|---|---|
| OCD group | Active comparator | OCD patients will receive rTMS treatment for 6 weeks. Receives: Device: Repetitive transcranial magnetic stimulation |
| HC group | No intervention | Health control will not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity.
Measured: Change from Baseline at 6weeks
Secondary outcomes (5)
Hamilton Depression Scale (HAMD-17)
It is one of the most widely used examiner-rating depression scales, which contains 17 items. It is used to measure the severity of depression and its change in treatment. The total score range is 0-59, and a lower score means a better outcome.
Measured: Change from Baseline at 6weeks
Hamilton Anxiety Scale (HAMA-14)
It is one of the most widely used examiner-rating anxiety scales, which contains 14 items. It is used to measure the severity of anxiety and its change in treatment. The scoring method adopts a five-point scale of 0-4 points. The total score range is 0-56 and a lower score means a better outcome.
Measured: Change from Baseline at 6weeks
Florida Obsessive Compulsive Inventory (FOCI)
FOCI, a self-rating scale, is used to assess the severity of obsessive-compulsive symptoms within one month, which contains 20 items. The first 15 items are evaluated the symptoms by yes and no, and the last 5 items are evaluated the severity of symptoms on 0-4 five-point scale. The total score range is 0-20 and a lower score means a better outcome.
Measured: Change from Baseline at 6weeks
Obsessive Belief Questionnaire (OBQ-44)
It is a self-rating scale to assess the severity of the obsessive belief, which contains 44 items. The scoring method adopts a seven-point scale of 1-7 points. The total score range is 44-308 and a lower score means a better outcome.
Measured: Change from Baseline at 6weeks
State-Trait Anxiety Inventory (STAI)
It is one of the most widely used self-rating anxiety scales, which contains 40 items. The first 20 items are used to measure the state anxiety and the last 20 items are used to measure trait anxiety. The scoring method adopts a four-point scale of 1-4 points. Both the total score range of state anxiety and trait anxiety are 20-80 and a lower score means a better outcome.
Measured: Change from Baseline at 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Fan, Doctor, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563935
- Sponsor's protocol ID
- 2021-51
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT05563935
- Acronym / sponsor ID
- 2021-51
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Case-control study, Repetitive transcranial magnetic stimulation, Decision-making confidence, Metabolism, Neural network, GABA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Oct 2022 (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.
This study, a case-control study, aims to investigate the function-metabolism coupling in decision-making confidence neural network of obsessive-compulsive disorder.
Detailed description
OCD shows various abnormalities in cognitive function. Decision-making confidence is a burgeoning research focus on cognitive abnormality of OCD. Gamma-aminobutyric acid (GABA) is a type of inhibitory amino acid. Some studies have indicated that GABA shows metabolic abnormality in OCD.
Repetitive transcranial magnetic stimulation (rTMS) is a safe and noninvasive treatment for OCD. This study intends to explore the differences of the function-metabolism coupling in decision-making confidence neural network between OCD and HC. And investigating the dynamic changes of the function-metabolism coupling after rTMS treatment (6 weeks) for OCD is another goal.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCD group | Active comparator | Device: Repetitive transcranial magnetic stimulationOCD patients will receive rTMS treatment for 6 weeks. |
| HC group | No intervention | –Health control will not receive any treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age between 18 and 50 years.
- Satisfied with the diagnostic criteria for OCD in DSM-V.
- Taking medication or unmedication stably for 8 weeks or drug-naive.
- YBOCS score ≥16.
- Education level was limited to above middle school.
Key exclusion criteria (17 listed)
- Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
- HAMD-17 score ≥ 17.
- IQ < 70.
- Obsessive-compulsive symptoms were too severe to participate in the experiment.
- Hoarding symptom.
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationThe OCD group will receive rTMS treatment for 6 weeks. There are 5 rTMS treatments per week (Monday to Friday), and 30 rTMS treatments in total. Treatment is administered by Ma GPro X100 device (Maga Venture) with Cool-DB80 coil. Detailed parameters of rTMS: intensity of stimulus is 120% RMT; the frequency of trains is 1Hz and the number of pulses is 1; no intertrain intervals and the pulses number is 1000. | Device | OCD group |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time frame: Change from Baseline at 6weeks
YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity.
5 secondary outcomes
Hamilton Depression Scale (HAMD-17)
Time frame: Change from Baseline at 6weeks
Hamilton Anxiety Scale (HAMA-14)
Time frame: Change from Baseline at 6weeks
Florida Obsessive Compulsive Inventory (FOCI)
Time frame: Change from Baseline at 6weeks
Obsessive Belief Questionnaire (OBQ-44)
Time frame: Change from Baseline at 6weeks
State-Trait Anxiety Inventory (STAI)
Time frame: Change from Baseline at 6weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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.
Qing Fan, Doctor study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
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 17 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 3 Oct 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qihui Guo (15221398831, guoharry@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive-Compulsive Scale (YBOCS) (time frame: Change from Baseline at 6weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2022.