Major Depressive DisorderPhase 1/2NCT00581009
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
A Phase 1/2 study testing chronobiological augmentation, sertraline, lithium and one night of sleep deprivation and two FDG PET scans in people with Major Depressive Disorder and Bipolar Disorder, run by University of California, Irvine at 2 sites in United States.
Trial summary
This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder
- What is being tested?
- chronobiological augmentation, sertraline, lithium and one night of sleep deprivation and two FDG PET scans
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2001to 9 Dec 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be English speaking
- Subjects must have either bipolar or unipolar depression diagnosis or be a normal control.
- Subjects must be between : 18 to 75
- Non-English speaking subjects will be excluded since scales for measuring depression have not been validated in languages other than English.
Who cannot join
- Suicidality, or psychosis
- Unstable medical conditions
- Epilepsy, serious head injury, or other significant neurological disorders
- Dementia, mental retardation (moderate or severe), coma
- Prior exposure to radiation which might cause the subject to exceed standard guidelines
- Substance abuse or alcoholism in the past six months
Show all 18Show fewer
- Unreliability or inability to adhere to the requirements of the study
- Irregular sleep-wake schedules (nightshift, jet lag)
- Use of CNS medications which may affect sleep or functional brain imaging (i.e., use of sleeping pills, antidepressants or other mood stabilizers or other medications which may affect the sleep EEG)
- Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders
- Donation or loss of blood (>400 ml) within the past month
- Current or very recent intercurrent illnesses, painful conditions or other disorders, which in the judgement of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for the subject.
- Hamilton Rating Scale of Depression (HRSD-17 items)<17 unless subject is a normal control subject.
- Pregnancy or breast feeding
- Individuals who would be unable to undergo a magnetic resonance imaging (MRI) scan, for example, individuals who suffer from claustrophobia, or who have metal clips in their body.
- Unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to PET scans.
- Patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other SSRI's such as Paxil or Prozac
- Subjects with diagnosis of eating disorder/bulimia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Irvine
Irvine, California, 92697
University of California, San Diego
La Jolla, California, 92093 - 0603
About this study
This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Being tested
- chronobiological augmentation, sertraline, lithium, one night of sleep deprivation and two FDG PET scans
- Keywords
- Sleep deprivation, antidepressant, depression, chronobiological
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Sleep Deprivation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronobiological augmentationOther
Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days
sertraline, lithiumDrug
Also called Zoloft, Lithium
Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.
Mood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks.
one night of sleep deprivation and two FDG PET scansRadiation
MDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility.
| Study group | Role | What they receive |
|---|---|---|
| Chronobiological augmentation | Experimental | chronobiological augmentation group Receives: Other: chronobiological augmentation |
| Medication only | Experimental | medication only group Receives: Drug: sertraline, lithium |
| MDD Mechanism | Experimental | Not described Receives: Radiation: one night of sleep deprivation and two FDG PET scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version
Difference in HRSD between the chronobiological augmentation therapy and medication only groups across the first 7 days, and up to 7 weeks of treatment. The 21-item HRSD has a range of 0 to 66, with a higher score indicating more severe depression.
Measured: within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study start30 May 2001
- Primary completion9 Dec 2011
- Study completion9 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Joseph Wu, University of California, Irvine
- Investigators
- Barry F Chaitin, M.D., Study chair, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581009
- Sponsor's protocol ID
- 20011616
- Status last verified
- Oct 2024
- First submitted
- 19 Dec 2007
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
- ClinicalTrials.gov ID
- NCT00581009
- Acronym / sponsor ID
- 20011616
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Keywords
- Sleep deprivation, antidepressant, depression, chronobiological
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 30 May 2001 (actual)
- Primary completion
- 9 Dec 2011 (actual)
- Study completion
- 9 Dec 2011 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 17 Oct 2024
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 the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronobiological augmentation | Experimental | Other: chronobiological augmentationchronobiological augmentation group |
| Medication only | Experimental | Drug: sertraline, lithiummedication only group |
| MDD Mechanism | Experimental | Radiation: one night of sleep deprivation and two FDG PET scans |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be English speaking
- Subjects must have either bipolar or unipolar depression diagnosis or be a normal control.
- Subjects must be between : 18 to 75
- Non-English speaking subjects will be excluded since scales for measuring depression have not been validated in languages other than English.
Key exclusion criteria (18 listed)
- Suicidality, or psychosis
- Unstable medical conditions
- Epilepsy, serious head injury, or other significant neurological disorders
- Dementia, mental retardation (moderate or severe), coma
- Prior exposure to radiation which might cause the subject to exceed standard guidelines
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 |
|---|---|---|
| chronobiological augmentationSleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days | Other | Chronobiological augmentation |
| sertraline, lithiumAlso: Zoloft, LithiumAntidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks. Mood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks. | Drug | Medication only |
| one night of sleep deprivation and two FDG PET scansMDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility. | Radiation | MDD Mechanism |
Primary outcome
Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version
Time frame: within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy
Difference in HRSD between the chronobiological augmentation therapy and medication only groups across the first 7 days, and up to 7 weeks of treatment. The 21-item HRSD has a range of 0 to 66, with a higher score indicating more severe depression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Barry F Chaitin, M.D. study chair
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing chronobiological augmentation, sertraline, lithium and one night of sleep deprivation and two FDG PET scans in people with Major Depressive Disorder and Bipolar Disorder, run by University of California, Irvine at 2 sites 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 4 inclusion and 18 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version (time frame: within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy). 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 17 Oct 2024.