Unipolar DepressionWakeTherapyNCT02750631
Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
A study testing Triple Therapy in people with Unipolar Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times ending at their desired sleep time. Beginning the morning following their Wake Night, patients sit in front of a bright light, continuing morning bright light and specified sleep time for six weeks with weekly visits measuring… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Triple Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2017
- 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
- major depressive disorder or persistent depressive disorder or unspecified depressive disorder
- physically healthy
- patients over age 60 need primary care physician's approval, electrocardiogram and Mini Mental Status Examination
Who cannot join
- medically unstable condition
- bipolar disorder
- current (past six months) substance use disorder
- significant suicide risk
- need for hospitalization
- history of psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times ending at their desired sleep time. Beginning the morning following their Wake Night, patients sit in front of a bright light, continuing morning bright light and specified sleep time for six weeks with weekly visits measuring depressive symptoms.
Read the detailed description
Nonpsychotic, nonbipolar, physically healthy depressed patients keep sleep, mood and energy logs for a week, complete the Morningness-Eveningness Questionnaire (measuring "morningness" and "eveningness") and determine the time patients want to sleep. Patients then miss a night of sleep and subsequently are allowed later and later sleep times until patients are sleeping at their desired time. Beginning the morning following their Wake Night, patients sit in front of bright lights at their intended wake-up time for the next six weeks and once their allowed sleep time is their intended sleep time, patients also continue to only be allowed to sleep between those times (e.g., 11 p.m. to 7 a.m.). Daily sleep, energy and mood logs and activity monitoring are maintained throughout with weekly clinician ratings. In additional, daily telephone check ins occur during the first week following the Wake Night both to be sure the patient is following the protocol and to obtain symptom ratings. Saliva to be measured for melatonin is collected prior to and following sleep adjustment.
- Conditions
- Unipolar Depression
- Being tested
- Triple Therapy
- Keywords
- depression, melatonin, light therapy, Wake Therapy, chronobiology
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple TherapyOther
Also called Chronotherapeutics
The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance
| Study group | Role | What they receive |
|---|---|---|
| Triple Therapy | Experimental | Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance Receives: Other: Triple Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Rating Scale for Depression
The Hamilton Rating Scale for Depression is a standard clinician scored rating of depressed mood and the symptoms commonly associated with clinical depression
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients receive Chronotherapy, which consists of a night of no sleep ("Wake Therapy") followed by bright lights at their desired sleep time and two nights of Sleep Phase Advance (i.e., sleeping 6 hours earlier than desired for 1 night and 3 hours earlier for the next night, then desired sleep time).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan W Stewart, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750631
- Sponsor's protocol ID
- 6938
- Acronym
- WakeTherapy
- Status last verified
- Aug 2017
- First submitted
- 20 Apr 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: No such plan at present
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
- ClinicalTrials.gov ID
- NCT02750631
- Acronym / sponsor ID
- WakeTherapy / 6938
- Conditions
- Unipolar Depression
- Keywords
- depression, melatonin, light therapy, Wake Therapy, chronobiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 Apr 2016 (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.
Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times ending at their desired sleep time. Beginning the morning following their Wake Night, patients sit in front of a bright light, continuing morning bright light and specified sleep time for six weeks with weekly visits measuring depressive symptoms.
Detailed description
Nonpsychotic, nonbipolar, physically healthy depressed patients keep sleep, mood and energy logs for a week, complete the Morningness-Eveningness Questionnaire (measuring "morningness" and "eveningness") and determine the time patients want to sleep. Patients then miss a night of sleep and subsequently are allowed later and later sleep times until patients are sleeping at their desired time. Beginning the morning following their Wake Night, patients sit in front of bright lights at their intended wake-up time for the next six weeks and once their allowed sleep time is their intended sleep time, patients also continue to only be allowed to sleep between those times (e.g., 11 p.m. to 7 a.m.). Daily sleep, energy and mood logs and activity monitoring are maintained throughout with weekly clinician ratings. In additional, daily telephone check ins occur during the first week following the Wake Night both to be sure the patient is following the protocol and to obtain symptom ratings. Saliva to be measured for melatonin is collected prior to and following sleep adjustment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients receive Chronotherapy, which consists of a night of no sleep ("Wake Therapy") followed by bright lights at their desired sleep time and two nights of Sleep Phase Advance (i.e., sleeping 6 hours earlier than desired for 1 night and 3 hours earlier for the next night, then desired sleep time).
| Arm | Type | Receives |
|---|---|---|
| Triple Therapy | Experimental | Other: Triple TherapyCombined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- major depressive disorder or persistent depressive disorder or unspecified depressive disorder
- physically healthy
- patients over age 60 need primary care physician's approval, electrocardiogram and Mini Mental Status Examination
Key exclusion criteria (6 listed)
- medically unstable condition
- bipolar disorder
- current (past six months) substance use disorder
- significant suicide risk
- need for hospitalization
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 |
|---|---|---|
| Triple TherapyAlso: ChronotherapeuticsThe intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance | Other | Triple Therapy |
Primary outcome
17-item Hamilton Rating Scale for Depression
Time frame: 1 week
The Hamilton Rating Scale for Depression is a standard clinician scored rating of depressed mood and the symptoms commonly associated with clinical depression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: Undecided. No such plan at present
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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.
Jonathan W Stewart, M.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple Therapy in people with Unipolar Depression, run by New York State Psychiatric Institute at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 29 Aug 2017. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
17-item Hamilton Rating Scale for Depression (time frame: 1 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 29 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.