CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a single-arm Clinical Trial

CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a single-arm Clinical Trial - CLEAR Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000040361

Enrollment

Registered

2020-05-11

Start date

2020-05-18

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

Cognitive Behavioral Therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects with DSM-IV Major Depressive Disorder based on Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder (SCID) at screening. 2. Subjects with HAMD-17 score >=14 at screening. 3. Subjects who give full consent in the participation of the study.

Exclusion criteria

Exclusion criteria: 1. No comorbid alcohol or substance use disorder in 2 years prior to the screening. 2. No history or concurrent manic or psychotic episode. 3. No other primary DSM-IV Axis I Disorders in 6 months prior to the screening. 4. No comorbid of antisocial personality disorder. 5. No serious and imminent suicidal ideation at screening. 6. Unlikely to attend more than 8 visits during the 16-week trial phase (eg, due to relocation). 7. Have previously completed an individual CBT program. 8. No organic brain lesions or major cognitive deficits in a year prior to the screening. 9. No severe or unstable medical illness at screening. 10. Contraindication to MRI (including cardiac pacemaker, claustrophobia)

Design outcomes

Primary

Measure	Time frame
Bold signal during rumination task recorded by fMRI	—

Secondary

Measure	Time frame
-Depression symptoms: GRID-Hamilton Depression Rating Scale, Beck Depression Inventory, Quick Inventory of Depressive Symptomatology -Remission: defined as HAMD-17=<7 -Response: defined as 50% reduction of baseline HAMD-17total score -Anxiety symptoms: Generalized Anxiety Disorder -7 - Hopelessness: Beck Hopelessness Scale -Rumination : Ruminative Response Scale -Aboidance: Cognitive-Behavioral Avoidance Scale -Coping: Coping Inventory for Stressful Situations -Disability: Sheehan Disability Scale -QOL: EuroQol -resting state functional connectivity (resting-fMRI) -Cognition on future-thinking: future-thinking task -Cognitive function: CABTAB or The Brief Assessment of Cognition in Schizophrenia: BACS-J	—

Measure

Time frame

-Depression symptoms: GRID-Hamilton Depression Rating Scale, Beck Depression Inventory, Quick Inventory of Depressive Symptomatology -Remission: defined as HAMD-17=<7 -Response: defined as 50% reduction of baseline HAMD-17total score -Anxiety symptoms: Generalized Anxiety Disorder -7 - Hopelessness: Beck Hopelessness Scale -Rumination : Ruminative Response Scale -Aboidance: Cognitive-Behavioral Avoidance Scale -Coping: Coping Inventory for Stressful Situations -Disability: Sheehan Disability Scale -QOL: EuroQol -resting state functional connectivity (resting-fMRI) -Cognition on future-thinking: future-thinking task -Cognitive function: CABTAB or The Brief Assessment of Cognition in Schizophrenia: BACS-J

—

Countries

Japan

Contacts

Public ContactNariko Katayama

Keio University School of Medicine Department of Neuropsychiatry

narikoktym@keio.jp03-5363-3971

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026