NCT07417709

Brief Summary

APhyDeM is a randomized controlled study investigating the relationship between adapted physical activity and mitochondrial function in postmenopausal women with major depressive disorder. Depression is associated with metabolic dysfunction, including alterations in mitochondrial activity and inflammatory processes. Physical activity has been shown to influence mitochondrial function, yet individuals with depression frequently experience reduced physical activity levels. This study aims to evaluate whether an adapted physical activity program can improve mitochondrial function compared with a control intervention. Mitochondrial function will be indirectly assessed using near-infrared spectroscopy to measure post-exercise muscle oxygen recovery kinetics. The study compares adapted physical activity with a non-physical therapeutic intervention in postmenopausal women receiving care in a psychiatric day hospital setting.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
30mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Feb 2026Nov 2028

Study Start

First participant enrolled

February 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

February 18, 2026

Status Verified

November 1, 2025

Enrollment Period

2.7 years

First QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

Menopausal DepressionDepression - Major Depressive Disorder

Keywords

postmenopausal womenmajor depressive disorderadapted physical activity

Outcome Measures

Primary Outcomes (1)

  • K recovery constant

    Relative difference of K recovery constant (min-1) reflecting the recovery speed of muscular oxygenation, assessed with muscular near-infrared spectroscopy (NIRS) at week 8, comparing with pre-randomization value. This measure is assessed at rest and following mitochondrial activation by MOTOmed15 movement therapy.

    Week 8

Secondary Outcomes (14)

  • Recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics.

    Baseline, Week 8 (end of intervention), and Week 12 (4 weeks post-intervention).

  • Relative change in recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics.

    Week 8 (end of intervention) and Week 12 (4 weeks post-intervention)

  • Depressive symptomatology

    Baseline, Week 8, and Week 12

  • Fatigue

    Baseline, Week 8, and Week 12

  • Suicidal ideation

    Baseline, Week 8, and Week 12

  • +9 more secondary outcomes

Study Arms (2)

Adaptated Physical Activity (APA)

EXPERIMENTAL

APA

Other: APA

Art therapy

ACTIVE COMPARATOR

Art therapy performed in routine healthcare

Other: CCATTP

Interventions

CCATTPOTHER

2 sessions/week of 2 hours art therapy. This approach is already used in routine healthcare and is not a procedure specific to the study.

Art therapy
APAOTHER

3 sessions/week of APA (1h yoga, 1h dance, 1h muscle strengthening)

Adaptated Physical Activity (APA)

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who self-identify as female are eligible to participate.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Menopaused women aged ≥ 40 years old,
  • Suffering from a major depressive episode according to international Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V)
  • Presenting a score ≥11 on the 16-item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) depression scale
  • With a stabilized teatment by antidepressors since at least 4 weeks

You may not qualify if:

  • Medical contraindication for physical activity (cardio-vascular pathology, and/or previous cardiac disease)
  • Asthma or other unstabilized condition impairing the ability to perform physical exertion
  • Adipose tissue thickness measured on the forearm \> 12 mm causing muscle oxygenation measurement by NIRS to be non contributive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Djamila BENNABI, MD PhD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine CHARRIERE, PhD

CONTACT

+33 3 81 21 89 99kcharriere@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

February 18, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)