Effect of a Single Nights' Wake Followed by Bright Light Therapy for Severe Depression

Depression Clinical Trial

Official title:

Wake and Bright Light Therapy for Depression Among Admitted Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02503124
• Other study ID #: CB001
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2021
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Depressive episode requiring admission to a psychiatric hospital (including unipolar and bipolar depression).

Exclusion Criteria:

• Psychotic symptoms/agitation
• Compulsory admission
• Confusion
• Active substance use disorder
• Eye disease preventing bright light therapy

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Single night's wake therapy
Eligible patients are assisted in maintaining total sleep deprivation during one night

Device:
• Bright light
Bright light according to patients´ own circadian rhythm each morning for a week.

Other:
• Treatment as usual - inpatient care
All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.
• Informative meeting
A short sleep hygiene consultation.

Drug:
• Treatment as usual - medicine
Since all patients are admitted due to a severe mental illness, they will receive medication according to indication. Most patients have already tried more than one antidepressant at the time of admission. In cases of severe anxiety, anxiolytics are prescribed but this is kept to a minimum.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS-S score reduction of 50%	Montgomery Asberg Depression Rating Scale	One week
Secondary	MADRS-S score at discharge	Montgomery Asberg Depression Rating Scale	Participants will be followed at discharge, an expected average of 2-3 weeks
Secondary	MADRS-S score at follow-up	Montgomery Asberg Depression Rating Scale	10-14 weeks
Secondary	ISI score score at discharge	Insomnia Severity Index - Self administered scale of sleep quality	Participants will be followed at discharge, an expected average of 2-3 weeks
Secondary	ISI score score at follow-up	Insomnia Severity Index - Self administered scale of sleep quality	10-14 weeks
Secondary	ISI score reduction of 50%	Insomnia Severity Index - Self administered scale of sleep quality	One week
Secondary	Length of stay	Patients will be followed up 10-14 weeks after discharge and the total number of days in inpatient services calculated.	The number of days between admission and discharge
Secondary	Re-admission		10-14 weeks
Secondary	CGI score	Clinical global impression	One week
Secondary	CGI score	Clinical global impression	10-14 weeks
Secondary	Medication use	The use of antidepressants, anxiolytics or other psychiatric medication will be registered at follow-up. The number of patients using more than one medication and the dosage will be compared.	10-14 weeks