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NCT06937476Fut, nem toboroz

Neurobiological Mechanisms of Pathological Rumination and Effects of Aripiprazole

Investigation of the Neurobiological Mechanisms Underlying Pathological Rumination and the Pharmacological Effects of Aripiprazole

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 12.

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Rövid összefoglaló (regiszter, angolul)

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 depressive disorder (MDD). Pathological rumination-defined as repetitive, intrusive, and uncontrollable negative thinking-has been identified as a major transdiagnostic risk factor for the development, maintenance, and recurrence of depression. Even during clinical remission, ruminative symptoms often persist and strongly predict relapse. Previous clinical observations and experimental studies suggest that aripiprazole, a partial dopamine D2 receptor agonist, can significantly improve cognitive symptoms and reduce rumination in MDD patients when added to selective serotonin reuptake inhibitors (SSRIs). However, rigorous randomized controlled trials (RCTs) directly targeting rumination and validating this effect remain limited. In this study, patients with acute MDD episodes and high levels of rumination will be randomly assigned to receive either escitalopram monotherapy (20 mg/day) or escitalopram (20 mg/day) plus low-dose aripiprazole (2.5-5 mg/day) for 8 weeks. Clinical assessments will be repeated during the 8-week treatment phase, including interim monitoring visits for efficacy and safety. The primary clinical endpoint is the change in Ruminative Responses Scale (RRS) scores from baseline to week 8.The assignment will remain blinded to outcome assessors and data analysts, while patients and treating clinicians will remain unblinded due to dose titration and safety monitoring requirements. Participants will undergo [18F]fallypride-PET-MRI scanning at baseline and and again at week 10, after tapering and discontinuation of aripiprazole during weeks 9-10, to measure striatal dopamine D2 receptor binding and explore its association with changes in rumination symptoms and treatment efficacy. The primary outcome is the change in Ruminative Responses Scale (RRS) scores. Secondary outcomes include changes in depressive symptoms and dopamine D2 receptor availability. This trial will provide neurobiological insights into the dopaminergic mechanisms underlying pathological rumination and explore the therapeutic potential of D2 receptor modulation in this cognitive domain.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
108 (tényleges)
Első benyújtás
2025. ápr. 20.
Kezdés
2025. máj. 8.
Elsődleges befejezés
2026. ápr. 8.
Fő szponzor
Central South University
Betegségek
Depresszió
NCT-szám
NCT06937476

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 108
  • 2025. máj. 8. és az elsődleges befejezés (2026. ápr. 8.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Receipt of electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or structured psychotherapy within the past 6 months

Más betegség

  • For Patients With Major Depressive Disorder (MDD):
  • Meets DSM-5 diagnostic criteria for any psychiatric disorder other than anxiety disorders
  • Major depressive disorder with psychotic features
  • History of traumatic brain injury or loss of consciousness
  • Serious neurological or medical illness that, in the judgment of the investigators, may affect study participation or data interpretation, including but not limited to thyroid disorders, lupus, diabetes, active infection, or major trauma
  • Cardiac pacemaker or any metallic implant incompatible with MRI or PET
  • History of alcohol or substance dependence
  • Personal history of epilepsy or family history of epilepsy in a first-degree relative
  • Receipt of non-pharmacological psychiatric interventions within the past 6 months, including electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or structured psychotherapy
    • For Healthy Controls:
  • Meets DSM-5 diagnostic criteria for any current or past psychiatric disorder
  • First-degree relative with a history of major psychiatric disorder
  • History of traumatic brain injury or loss of consciousness
  • Serious neurological or medical illness that, in the judgment of the investigators, may affect study participation or data interpretation, including but not limited to thyroid disorders, lupus, diabetes, active infection, or major trauma
  • Cardiac pacemaker or any metallic implant incompatible with MRI or PET
  • History of alcohol or substance dependence
  • Personal history of epilepsy or family history of epilepsy in a first-degree relative

Egyéb

  • Severe suicidal ideation or suicidal behavior
  • Pregnant or breastfeeding
  • Severe suicidal ideation or suicidal behavior
  • Pregnant or breastfeeding

Kiket keres a vizsgálat

  • For Patients With Major Depressive Disorder (MDD):
  • Age 18 to 45 years
  • Any sex
  • Self-identified Han Chinese
  • Right-handed
  • Education level of junior high school or above
  • Able to understand the informed consent form and complete self-report assessments
  • Meets DSM-5 diagnostic criteria for Major Depressive Disorder (MDD) based on the Structured Clinical Interview for DSM-5 (SCID)
  • Currently experiencing a major depressive episode
  • 24-item Hamilton Depression Rating Scale (HAMD-24) score >= 21 at screening/baseline
  • Young Mania Rating Scale (YMRS) score <= 5 at screening/baseline
  • No psychotropic medication use, other than benzodiazepines, within 6 weeks before baseline
    • Pathological Rumination Group:
  • Must meet all of the following criteria:
  • Subjective experience of persistent and difficult-to-control ruminative thinking
  • Interview-confirmed pathological rumination characterized by all of the following features:
  • Repetitive
  • Intrusive
  • Difficult to disengage from
  • Unproductive
  • Occupying substantial mental resources
  • Ruminative Responses Scale (RRS) score >= 61
    • Low Rumination Group:
  • Does not meet criteria for the Pathological Rumination Group
  • Ruminative Responses Scale (RRS) score < 61
    • For Healthy Controls:
  • Age 18 to 45 years
  • Any sex
  • Self-identified Han Chinese
  • Right-handed
  • Education level of junior high school or above
  • Able to understand the informed consent form and complete self-report assessments
  • Does not meet DSM-5 diagnostic criteria for any current or past psychiatric disorder based on the Structured Clinical Interview for DSM-5 (SCID)
  • 24-item Hamilton Depression Rating Scale (HAMD-24) score < 8 at screening/baseline
  • Young Mania Rating Scale (YMRS) score <= 5 at screening/baseline
  • No psychotropic medication use within 6 weeks before baseline

Életkor a regiszterben: 18 év – 45 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
The Second Xiangya Hospital of Central South UniversityChangshaKínaIsmeretlen állapot

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