Depression, UnipolarNCT03169543
Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation
A study testing Sleep deprivation in people with Depression, Unipolar, run by University of Pennsylvania at 1 site in United States.
Trial summary
From 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect have not been elucidated. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Unipolar
- What is being tested?
- Sleep deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 28 Feb 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current depression as assessed on the HDRS-17 (for depressed group only)
- Body mass index within 15% of normal
- Stable, normally-timed sleep-wake cycle defined by: a. Habitual nocturnal sleep duration between 6h and 9h. b. Habitual morning awakening between 0600h and 0800h.
- Able to comprehend English, as all questionnaires are in this language
- Ability to provide informed consent
Who cannot join
- Shift work, transmeridian travel or irregular sleep/wake routine in past 60 days
- A sleep disorder other than insomnia
- History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders
- No history of depression for the control group.
- Alcohol or drug abuse in the past year
- A current smoker.
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- Any acute or chronic, debilitating medical conditions, epilepsy, or thyroid disease.
- Metallic implants, pacemakers or tattoos, or history of working in metal workshops.
- Claustrophobic, or intolerant of the scanner environment.
- For women, pregnancy will exclude participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
From 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect have not been elucidated. Recent advances in functional neuroimaging have provided new opportunities to investigate state changes in regional brain function, along with a better understanding of the neural networks affected by depression and SD. Here we propose to study a group of N=48 antidepressant-free male and female patients with current depression symptom and N=12 healthy controls with no history of mood disorders before and after SD to provide mechanistic insight into the neural substrates underlying the antidepressant effects of SD. We hypothesize that SD-induced concurrent functional activity and connectivity changes in multiple brain networks related to different depressive symptom dimensions including emotion regulation, attention, arousal, self-referential, and reward processing will underlie the rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing data will be acquired at baseline after normal sleep, during one night of total SD, and after one night of recovery sleep using a 5-day in laboratory protocol during which subjects will be continuously monitored by trained staff.
- Conditions
- Depression, Unipolar
- Being tested
- Sleep deprivation
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationBehavioural
36-hours total sleep deprivation
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | 36-hours of total sleep deprivation Receives: Behavioral: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HAMD-NOW scores
Total score on a modified Hamilton Depression Inventory that assesses mood symptoms in the moment.
Measured: Each morning for 4 days
Secondary outcomes (1)
Change in neuroimaging
Resting-state brain functional connectivity on fMRI
Measured: Each morning for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Apr 2016
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Gehrman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169543
- Sponsor's protocol ID
- 811678
- Status last verified
- Mar 2020
- First submitted
- 24 May 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation
- ClinicalTrials.gov ID
- NCT03169543
- Acronym / sponsor ID
- 811678
- Conditions
- Depression, Unipolar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 30 May 2017 (actual)
- 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.
From 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect have not been elucidated. Recent advances in functional neuroimaging have provided new opportunities to investigate state changes in regional brain function, along with a better understanding of the neural networks affected by depression and SD. Here we propose to study a group of N=48 antidepressant-free male and female patients with current depression symptom and N=12 healthy controls with no history of mood disorders before and after SD to provide mechanistic insight into the neural substrates underlying the antidepressant effects of SD. We hypothesize that SD-induced concurrent functional activity and connectivity changes in multiple brain networks related to different depressive symptom dimensions including emotion regulation, attention, arousal, self-referential, and reward processing will underlie the rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing data will be acquired at baseline after normal sleep, during one night of total SD, and after one night of recovery sleep using a 5-day in laboratory protocol during which subjects will be continuously monitored by trained staff.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Behavioral: Sleep deprivation36-hours of total sleep deprivation |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Current depression as assessed on the HDRS-17 (for depressed group only)
- Body mass index within 15% of normal
- Stable, normally-timed sleep-wake cycle defined by: a. Habitual nocturnal sleep duration between 6h and 9h. b. Habitual morning awakening between 0600h and 0800h.
- Able to comprehend English, as all questionnaires are in this language
- Ability to provide informed consent
Key exclusion criteria (10 listed)
- Shift work, transmeridian travel or irregular sleep/wake routine in past 60 days
- A sleep disorder other than insomnia
- History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders
- No history of depression for the control group.
- Alcohol or drug abuse in the past year
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 |
|---|---|---|
| Sleep deprivation36-hours total sleep deprivation | Behavioural | Sleep deprivation |
Primary outcome
Change in HAMD-NOW scores
Time frame: Each morning for 4 days
Total score on a modified Hamilton Depression Inventory that assesses mood symptoms in the moment.
1 secondary outcome
Change in neuroimaging
Time frame: Each morning for 3 days
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 25 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Philip Gehrman, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation in people with Depression, Unipolar, run by University of Pennsylvania 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 5 inclusion and 10 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 25 Mar 2020. 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?
Change in HAMD-NOW scores (time frame: Each morning for 4 days). 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 25 Mar 2020.