Neurobiological Mechanisms of Pathological Rumination and Effects of Aripiprazole
Launched by CENTRAL SOUTH UNIVERSITY · Apr 20, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a medication called aripiprazole on people with Major Depressive Disorder (MDD) who experience persistent negative thinking, known as rumination. Rumination is when someone can't stop thinking about their problems or regrets, which can make depression worse or cause it to return even after treatment. The trial will compare two groups: one group will receive standard treatment with a medication called escitalopram alone, while the other group will get escitalopram along with aripiprazole for 8 weeks. Researchers will use brain scans to see how these medications affect both rumination and brain chemistry.
To participate in the trial, you need to be between 18 and 45 years old, right-handed, and currently experiencing a depressive episode with specific symptoms. You should also have high levels of rumination, as confirmed through an interview and a questionnaire. It's important to note that participants should not have other psychiatric disorders, severe suicidal thoughts, or certain medical conditions that could interfere with the study. If you join, you can expect to receive either of the two treatments and undergo brain scans before and after the study to help understand how the treatments work.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * 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:
- • 1. Subjective experience (e.g., "I can't stop thinking about past regrets" or "I can't control painful thoughts...")
- 2. Interview-confirmed features of pathological rumination (all of the following):
- • Repetitive Intrusive Difficult to disengage Unproductive Capturing mental capacity
- • 3. Ruminative Responses Scale (RRS) score ≥ 61
- • Low Rumination Group: Does not meet the above criteria.
- Exclusion Criteria:
- • 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.
About Central South University
Central South University is a prestigious academic institution located in Changsha, China, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive resources and expertise to conduct innovative research aimed at improving healthcare outcomes. Central South University collaborates with a diverse network of healthcare professionals and researchers, focusing on a wide range of therapeutic areas. The institution is dedicated to adhering to the highest ethical standards and regulatory requirements, ensuring the safety and efficacy of new treatments while contributing to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Yan Zhang
Principal Investigator
Central South University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported