DepressionSAGENCT04131868
Sleep and Girls' Emotions Study
A study testing Typical sleep opportunity and Extended sleep opportunity in people with Depression, run by University of Oregon at 1 site in United States.
Trial summary
This study evaluates whether increasing sleep duration can increase neural and behavioral response to rewards and decrease depressive symptoms in 18- to 22-year-old women with insufficient sleep and depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 22 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Typical sleep opportunity and Extended sleep opportunity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 7 Jul 2019
- 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 22 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Insufficient sleep (total sleep time < 8 hours per night, with sleepiness scores ≥ 6 on the Epworth Sleepiness Scale OR ≥ 16 on the PROMIS Sleep Related Impairment Scale)
- Symptoms of depression (≥ 15 on the Center for Epidemiological Studies for Depression Scale)
Who cannot join
- Current insomnia, hypersomnia, sleep disordered breathing, sleep movement disorder, or circadian rhythm disorder
- History of head injury with loss of consciousness within the past two years
- History of head injury with loss of consciousness two or more years ago and meet criteria for post concussion syndrome
- Neurological disorder
- Use of psychiatric medications
- Current psychotic symptoms
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- Active suicidal ideation
- Conditions that are contraindicated for MRI (e.g., ferromagnetic material in the body)
- Meet criteria for current substance use disorder with greater than mild severity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Contribution of Stressful Life Events and Insufficient Sleep to Reward-Related Brain Function and Depression in Adolescent Girls
This study evaluates whether increasing sleep duration can increase neural and behavioral response to rewards and decrease depressive symptoms in 18- to 22-year-old women with insufficient sleep and depressive symptoms.
- Conditions
- Depression
- Being tested
- Typical sleep opportunity, Extended sleep opportunity
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typical sleep opportunityBehavioural
Typical sleep opportunity with consistent sleep timing for 1 week
Extended sleep opportunityBehavioural
Extended sleep opportunity by 90 min per night with consistent sleep timing for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Extended sleep opportunity | Experimental | Not described Receives: Behavioral: Extended sleep opportunity |
| Typical sleep opportunity | Active comparator | Not described Receives: Behavioral: Typical sleep opportunity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Center for Epidemiological Studies Depression Scale score. The CESD-R is a 20-item measure of the frequency of depressive symptoms, with each item rated on a scale from 0 (not at all or less than one day) to 5 (nearly every day). Total scores range from 0 to 100, with higher scores indicating greater number and frequency of depressive symptoms.
Measured: 1 week
Reward-related brain function
BOLD fMRI response during Reward Guessing Task
Measured: 1 week
Sleep duration
Mean actigraphy-measured sleep duration
Measured: 1 week
Secondary outcomes (4)
Positive affect
International Positive and Negative Affect Scale Short Form - Positive Affect score. The I-PANAS-SF is a 10-item scale that asks participants to rate the extent to which 5 positive and 5 negative adjectives describe them on a scale of 1 (never) to 5 (always). Scores for each positive adjective are summed to produce a Positive Affect (PA) score ranging from 5 to 25, with higher scores indicating more positive affect.
Measured: 1 week
Negative affect
International Positive and Negative Affect Scale Short Form - Negative Affect score. The I-PANAS-SF is a 10-item scale that asks participants to rate the extent to which 5 positive and 5 negative adjectives describe them on a scale of 1 (never) to 5 (always). Scores for each negative adjective are summed to produce a Negative Affect (PA) score ranging from 5 to 25, with higher scores indicating more negative affect.
Measured: 1 week
Reward effort
Effort Expenditure for Rewards Task score
Measured: 1 week
Reward-related functional connectivity
BOLD fMRI psychophysiological striatal-medial prefrontal cortex interaction
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 posted18 Oct 2019
- Study start19 Feb 2018
- Primary completion25 Apr 2019
- Study completion7 Jul 2019
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melynda Casement, University of Oregon
- Investigators
- Melynda D Casement, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131868
- Sponsor's protocol ID
- K01MH103511
- Acronym
- SAGE
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Stressful Life Events and Insufficient Sleep to Reward-Related Brain Function and Depression in Adolescent Girls
- ClinicalTrials.gov ID
- NCT04131868
- Acronym / sponsor ID
- SAGE / K01MH103511
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 7 Jul 2019 (actual)
- First posted
- 18 Oct 2019 (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.
This study evaluates whether increasing sleep duration can increase neural and behavioral response to rewards and decrease depressive symptoms in 18- to 22-year-old women with insufficient sleep and depressive symptoms.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended sleep opportunity | Experimental | Behavioral: Extended sleep opportunity |
| Typical sleep opportunity | Active comparator | Behavioral: Typical sleep opportunity |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Insufficient sleep (total sleep time < 8 hours per night, with sleepiness scores ≥ 6 on the Epworth Sleepiness Scale OR ≥ 16 on the PROMIS Sleep Related Impairment Scale)
- Symptoms of depression (≥ 15 on the Center for Epidemiological Studies for Depression Scale)
Key exclusion criteria (9 listed)
- Current insomnia, hypersomnia, sleep disordered breathing, sleep movement disorder, or circadian rhythm disorder
- History of head injury with loss of consciousness within the past two years
- History of head injury with loss of consciousness two or more years ago and meet criteria for post concussion syndrome
- Neurological disorder
- Use of psychiatric medications
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 |
|---|---|---|
| Typical sleep opportunityTypical sleep opportunity with consistent sleep timing for 1 week | Behavioural | Typical sleep opportunity |
| Extended sleep opportunityExtended sleep opportunity by 90 min per night with consistent sleep timing for 1 week | Behavioural | Extended sleep opportunity |
Primary outcome
Depressive symptoms
Time frame: 1 week
Center for Epidemiological Studies Depression Scale score. The CESD-R is a 20-item measure of the frequency of depressive symptoms, with each item rated on a scale from 0 (not at all or less than one day) to 5 (nearly every day). Total scores range from 0 to 100, with higher scores indicating greater number and frequency of depressive symptoms.
Reward-related brain function
Time frame: 1 week
BOLD fMRI response during Reward Guessing Task
Sleep duration
Time frame: 1 week
Mean actigraphy-measured sleep duration
4 secondary outcomes
Positive affect
Time frame: 1 week
Negative affect
Time frame: 1 week
Reward effort
Time frame: 1 week
Reward-related functional connectivity
Time frame: 1 week
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 5 Nov 2019.
- 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.
Melynda D Casement, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Typical sleep opportunity and Extended sleep opportunity in people with Depression, run by University of Oregon 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 2 inclusion and 9 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 5 Nov 2019. 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?
Depressive symptoms (time frame: 1 week). The study lists 3 primary outcomes in all. 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 5 Nov 2019.