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Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Case-control study, Repetitive transcranial magnetic stimulation, Decision-making confidence, Metabolism, Neural network, GABA

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

OCD group:

  1. Age between 18 and 50 years.
  2. Satisfied with the diagnostic criteria for OCD in DSM-V.
  3. Taking medication or unmedication stably for 8 weeks or drug-naive.
  4. YBOCS score ≥16.
  5. Education level was limited to above middle school.
  6. Has sufficient audiovisual skills to complete the necessary examinations for the study.
  7. Right-handed (this criterion is for fMRI subjects only).
  8. Subjects understood the study and signed informed consent.

HC group:

  1. Match with the OCD group on age, gender, education years.
  2. Unsatisfied with the diagnostic criteria for any mental disorder in DSM-V.
  3. No history of taking psychotropic drugs.
  4. No family genetic history of mental disorder.
  5. Has sufficient audiovisual skills to complete the necessary examinations for the study.
  6. Right-handed (this criterion is for fMRI subjects only).
  7. Subjects understood the study and signed informed consent.

Exclusion Criteria:

OCD group:

  1. Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
  2. HAMD-17 score ≥ 17.
  3. IQ < 70.
  4. Obsessive-compulsive symptoms were too severe to participate in the experiment.
  5. Hoarding symptom.
  6. High risk of negative thought and suicide.
  7. Severe central system or physical disease or drug abuse.
  8. Pregnant women or women that getting ready for being pregnant and lactating.
  9. 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:

  1. High risk of negative thought and suicide.
  2. HAMD-17 score ≥ 17.
  3. IQ < 70.
  4. Severe central system or physical disease or drug abuse.
  5. Pregnant women or women that getting ready for being pregnant and lactating.
  6. 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)

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

OCD group

HC group

Arm Description

OCD patients will receive rTMS treatment for 6 weeks.

Health control will not receive any treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 22, 2022
Last Updated
September 28, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05563935
Brief Title
Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder
Official Title
A Study of Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, Case-control study, Repetitive transcranial magnetic stimulation, Decision-making confidence, Metabolism, Neural network, GABA

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCD group
Arm Type
Active Comparator
Arm Description
OCD patients will receive rTMS treatment for 6 weeks.
Arm Title
HC group
Arm Type
No Intervention
Arm Description
Health control will not receive any treatment.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Description
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.
Time Frame
Change from Baseline at 6weeks
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale (HAMD-17)
Description
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.
Time Frame
Change from Baseline at 6weeks
Title
Hamilton Anxiety Scale (HAMA-14)
Description
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.
Time Frame
Change from Baseline at 6weeks
Title
Florida Obsessive Compulsive Inventory (FOCI)
Description
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.
Time Frame
Change from Baseline at 6weeks
Title
Obsessive Belief Questionnaire (OBQ-44)
Description
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.
Time Frame
Change from Baseline at 6weeks
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Change from Baseline at 6weeks
Other Pre-specified Outcome Measures:
Title
Decision-making confidence
Description
The decision-making confidence is measure by randomized dot motion (RDM) task with a self-reported confidence scale (1-4 points). And a lower score means a lower decision-making confidence.
Time Frame
Change from Baseline at 6weeks
Title
The distribution and level of GABA in the brain
Description
Using the SPICE (an advanced MRI technology) to measure the distribution and level of gamma-aminobutyric acid (GABA) in the brain. The change of GABA metabolism will be observed during treatment.
Time Frame
Change from Baseline at 6weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qihui Guo
Phone
15221398831
Email
guoharry@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Fan, Doctor
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

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Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder

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