Status:
RECRUITING
Neurobiological Mechanisms of Pathological Rumination and Effects of Aripiprazole
Lead Sponsor:
Central South University
Collaborating Sponsors:
Second Xiangya Hospital of Central South University
National Natural Science Foundation of China
Conditions:
Major Depressive Disorder (MDD)
Rumination
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This randomized, single-blind (assessor-blind) controlled trial aims to investigate the efficacy of aripiprazole as an augmentation strategy for treating pathological rumination in patients with major...
Detailed Description
Revised Detailed Description（Single-Blind Assessor-Blind Version） Background: Pathological rumination is characterized by repetitive, intrusive, and difficult-to-control negative thinking that often...
Eligibility Criteria
Inclusion
- For Patients with Major Depressive Disorder (MDD):
- Age 18 to 45 years old, any sex.
- Han Chinese, right-handed.
- Education level of junior high school or above, able to understand informed consent and complete self-report instruments.
- Meets DSM-5 diagnostic criteria for Major Depressive Disorder (MDD) based on the SCID interview.
- Currently experiencing a depressive episode:
- HAMD-24 score ≥ 21
- YMRS score ≤ 5
- No psychotropic medication (except benzodiazepines) in the past 6 weeks.
- Classified into one of two cognitive subgroups based on rumination:
- Pathological Rumination Group: Must meet all three of the following:
- Subjective experience (e.g., "I can't stop thinking about past regrets" or "I can't control painful thoughts...")
- Interview-confirmed features of pathological rumination (all of the following):
- Repetitive Intrusive Difficult to disengage Unproductive Capturing mental capacity
- Ruminative Responses Scale (RRS) score ≥ 61
- Low Rumination Group: Does not meet the above criteria.
Exclusion
- Meets DSM-5 criteria for psychiatric disorders other than anxiety disorders.
- MDD with psychotic features.
- Severe suicidal ideation or behavior.
- History of traumatic brain injury or loss of consciousness.
- Serious neurological or medical illness (e.g., thyroid disorders, lupus, diabetes, infection, trauma).
- Cardiac pacemaker or any metallic implants incompatible with MRI/PET.
- History of alcohol or substance dependence.
- Pregnant or breastfeeding.
- Personal or family history of epilepsy.
- Underwent non-pharmacological psychiatric interventions (e.g., ECT, rTMS, psychotherapy) in the past 6 months.
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06937476
Start Date
May 8 2025
End Date
March 1 2026
Last Update
December 8 2025
Active Locations (1)
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1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011