DepressionNCT02503124
Effect of a Single Nights' Wake Followed by Bright Light Therapy for Severe Depression
A study testing Single night's wake therapy, Bright light and Treatment as usual - inpatient care in people with Depression, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Single night's wake therapy, Bright light and Treatment as usual - inpatient care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2015to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depressive episode requiring admission to a psychiatric hospital (including unipolar and bipolar depression).
Who cannot join
- Psychotic symptoms/agitation
- Compulsory admission
- Confusion
- Active substance use disorder
- Eye disease preventing bright light therapy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County
About this study
Official title: Wake and Bright Light Therapy for Depression Among Admitted Patients
A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual.
- Conditions
- Depression
- Being tested
- Single night's wake therapy, Bright light, Treatment as usual - inpatient care, Informative meeting, Treatment as usual - medicine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single night's wake therapyBehavioural
Also called Sleep deprivation
Eligible patients are assisted in maintaining total sleep deprivation during one night
Bright lightDevice
Bright light according to patients´ own circadian rhythm each morning for a week.
Treatment as usual - inpatient careOther
All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.
Informative meetingOther
A short sleep hygiene consultation.
Treatment as usual - medicineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronobiological intervention | Experimental | Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual. Receives: Behavioral: Single night's wake therapy; Device: Bright light; Other: Treatment as usual - inpatient care; Drug: Treatment as usual - medicine |
| Control | Active comparator | Treatment as usual including a private educational meeting in sleep hygiene. Receives: Other: Treatment as usual - inpatient care; Other: Informative meeting; Drug: Treatment as usual - medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS-S score reduction of 50%
Montgomery Asberg Depression Rating Scale
Measured: One week
Secondary outcomes (10)
MADRS-S score at discharge
Montgomery Asberg Depression Rating Scale
Measured: Participants will be followed at discharge, an expected average of 2-3 weeks
MADRS-S score at follow-up
Montgomery Asberg Depression Rating Scale
Measured: 10-14 weeks
ISI score score at discharge
Insomnia Severity Index - Self administered scale of sleep quality
Measured: Participants will be followed at discharge, an expected average of 2-3 weeks
ISI score score at follow-up
Insomnia Severity Index - Self administered scale of sleep quality
Measured: 10-14 weeks
ISI score reduction of 50%
Insomnia Severity Index - Self administered scale of sleep quality
Measured: One week
Length of stay
Patients will be followed up 10-14 weeks after discharge and the total number of days in inpatient services calculated.
Measured: The number of days between admission and discharge
Re-admission
Measured: 10-14 weeks
CGI score
Clinical global impression
Measured: One week
CGI score
Clinical global impression
Measured: 10-14 weeks
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.
Measured: 10-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Why it stopped: COVID-19 and re-organisation at the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steinn Steingrimsson, Sahlgrenska University Hospital
- Investigators
- Steinn Steingrimsson, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503124
- Sponsor's protocol ID
- CB001
- Status last verified
- Mar 2021
- First submitted
- 10 Jul 2015
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wake and Bright Light Therapy for Depression Among Admitted Patients
- ClinicalTrials.gov ID
- NCT02503124
- Acronym / sponsor ID
- CB001
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 and re-organisation at the hospital
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronobiological intervention | Experimental | Behavioral: Single night's wake therapy, Device: Bright light, Other: Treatment as usual - inpatient care, Drug: Treatment as usual - medicineSingle night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual. |
| Control | Active comparator | Other: Treatment as usual - inpatient care, Other: Informative meeting, Drug: Treatment as usual - medicineTreatment as usual including a private educational meeting in sleep hygiene. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Depressive episode requiring admission to a psychiatric hospital (including unipolar and bipolar depression).
Key exclusion criteria (5 listed)
- Psychotic symptoms/agitation
- Compulsory admission
- Confusion
- Active substance use disorder
- Eye disease preventing bright light therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single night's wake therapyAlso: Sleep deprivationEligible patients are assisted in maintaining total sleep deprivation during one night | Behavioural | Chronobiological intervention |
| Bright lightBright light according to patients´ own circadian rhythm each morning for a week. | Device | Chronobiological intervention |
| Treatment as usual - inpatient careAll patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication. | Other | Chronobiological intervention, Control |
| Informative meetingA short sleep hygiene consultation. | Other | Control |
| Treatment as usual - medicineSince 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. | Drug | Chronobiological intervention, Control |
Primary outcome
MADRS-S score reduction of 50%
Time frame: One week
Montgomery Asberg Depression Rating Scale
10 secondary outcomes
MADRS-S score at discharge
Time frame: Participants will be followed at discharge, an expected average of 2-3 weeks
MADRS-S score at follow-up
Time frame: 10-14 weeks
ISI score score at discharge
Time frame: Participants will be followed at discharge, an expected average of 2-3 weeks
ISI score score at follow-up
Time frame: 10-14 weeks
ISI score reduction of 50%
Time frame: One week
Length of stay
Time frame: The number of days between admission and discharge
Re-admission
Time frame: 10-14 weeks
CGI score
Time frame: One week
CGI score
Time frame: 10-14 weeks
Medication use
Time frame: 10-14 weeks
Results and safety
The study was stopped early (reason given: COVID-19 and re-organisation at the hospital). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steinn Steingrimsson, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single night's wake therapy, Bright light and Treatment as usual - inpatient care in people with Depression, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 and re-organisation at the hospital). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS-S score reduction of 50% (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.