Phase 2
N=68
Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT01545843 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Hamilton Rating Scale for Depression-17 Item Minus Sleep Items — 6.1; 8.1; 6.3 units on a scale — p=.202
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sleep scheduling (Behavioral); Fluoxetine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Rating Scale for Depression-17 Item Minus Sleep Items |
6.1; 8.1; 6.3 | .202 |
| SECONDARY Quick Inventory of Depressive Symptoms (QIDS) |
5.3; 6.9; 6.7 | — |
| SECONDARY Pittsburgh Sleep Quality Index |
6.00; 8.67; 6.85; 5.23; 6.07; 5.50 | — |
| SECONDARY Change in EEG Sleep Measures I: Total Sleep Time |
430.132; 439.208; 444.040; 435.382; 337.75; 332.909 | — |
| SECONDARY Change in EEG Sleep Measures II (Sleep Efficiency) |
89.7005; 91.6829; 92.8248; 90.7824; 93.3322; 92.9082 | — |
| SECONDARY Change in Neuropsychological Functioning: Memory |
77.118; 74.938; 76.095; 76.647; 81.529; 77.400 | — |
| SECONDARY Change in Neurologic Functioning: Reaction Time |
499.1545; 528.3513; 470.2942; 493.2579; 519.8196; 472.7244 | — |
| SECONDARY Neurological Function (Emotional Perception) |
83.54; 86.24; 88.83; 83.08; 88.15; 88.75 | — |
Summary
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.
Eligibility Criteria
Inclusion Criteria
- Between 18 and 65 years old
- Current major depressive episode
- Habitual TIB of 7 to 5 minutes; history of seizures
- Sleep disorders other than insomnia, such as sleep apnea and periodic limb movement disorder
- Current use of prescription, over-the-counter, or naturopathic remedies for sleep (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics) or depression (e.g., Sam-E, St. John's Wort)
- Currently working evening or midnight shift (subjects who have recently traveled across multiple time zones will be included at the discretion of the PI).
- Currently at risk for drowsy driving or employment that requires routine operation of transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous equipment.
- Known allergy, hypersensitivity or contraindication to study medication
- Females: pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT01545843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.