NCT04917419

Brief Summary

Bipolar disorder affects more than 1% of the population. This pathology is considered as one of the most serious psychiatric disorder because of it is high suicide rates. It impacts patients life quality on many aspects, and specially their sleeping and circadian Rhythms. This can lead to more severe symptoms up to for thymic relapses. It was shown that Luminotherapy and Psychoeducation Program have a positive impact on these type of symptoms.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress86%
Dec 2022Dec 2026

First Submitted

Initial submission to the registry

February 26, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

February 26, 2021

Last Update Submit

January 12, 2026

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Number of days in-hospital

    Number of days patients spent in the hospital

    Day 0 to Day 365

Study Arms (2)

Luminotherapy and Psychoeducation Program

EXPERIMENTAL
Other: Luminotherapy and /or Psychoeducation Program

Psychoeducation Program

ACTIVE COMPARATOR
Other: Luminotherapy and /or Psychoeducation Program

Interventions

Luminotherapy and /or Psychoeducation ProgramOTHER

TO complete

Luminotherapy and Psychoeducation ProgramPsychoeducation Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bipolar disorder (type 1 and 2 according to DSM V)
  • Mood Disorder Questionnaire MDQ ˂ 7
  • Sleeping and Circadian Rhythms Disorders
  • Under treatment

You may not qualify if:

  • No addiction except for tobacco
  • Narcolepsy
  • Sleep Apnea
  • Psychiatric comorbidities
  • Suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Central Study Contacts

Cécile BOISVERT

CONTACT

0033 5 16 52 61 18cecile.boisvert@ch-poitiers.fr

Study Design

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

Study Record Dates

First Submitted

February 26, 2021

First Posted

June 8, 2021

Study Start

December 5, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)