Bipolar Disorder, Major Depressive Disorder
Conditions
Keywords
Sleep deprivation, antidepressant, depression, chronobiological
Brief 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. 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.
Interventions
OTHERchronobiological augmentation
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
DRUGsertraline, 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.
RADIATIONone night of sleep deprivation and two FDG PET scans
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.
Sponsors
University of California, San Diego
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria include: 1. Subjects must be English speaking 2. Subjects must have either bipolar or unipolar depression diagnosis or be a normal control. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronobiological Augmentation chronobiological augmentation group
chronobiological augmentation: Chronobiological augmentation consists of sleep deprivation for one night, partial sleep phase advance for three nights and ight therapy for two hours for three days | 32 |
| Medication Only medication only group
medication as usual, including: sertraline, 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. | 17 |
| Total | 49 |
Baseline characteristics
| Characteristic | Medication Only | Chronobiological Augmentation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 32 Participants | 49 Participants |
| Age, Continuous | 40 years STANDARD_DEVIATION 14 | 39 years STANDARD_DEVIATION 13 | 39.3 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 17 participants | 32 participants | 49 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 7 Participants | 22 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 17 |
| other Total, other adverse events | 2 / 32 | 0 / 17 |
| serious Total, serious adverse events | 0 / 32 | 0 / 17 |
Outcome results
Primary
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.
Time frame: within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy
Population: Bipolar disorder subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronobiological Augmentation | Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version | Baseline | 19 Total score on a scale | Standard Deviation 6.7 |
| Chronobiological Augmentation | Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version | Day 7 | 10.2 Total score on a scale | Standard Deviation 7.3 |
| Chronobiological Augmentation | Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version | Week 7 | 10.1 Total score on a scale | Standard Deviation 9.6 |
| Medication Only | Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version | Baseline | 18.5 Total score on a scale | Standard Deviation 7.1 |
| Medication Only | Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version | Day 7 | 14.4 Total score on a scale | Standard Deviation 8 |
| Medication Only | Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version | Week 7 | 15.2 Total score on a scale | Standard Deviation 10.2 |
p-value: <0.05ANOVA