The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients

This study is currently recruiting participants.
Verified November 2010 by University of California, Irvine
Sponsor:
Collaborator:
University of California, San Diego
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581009
First received: December 19, 2007
Last updated: November 1, 2010
Last verified: November 2010

December 19, 2007
November 1, 2010
March 2001
January 2018   (final data collection date for primary outcome measure)
Hamilton Rating Score for Depression [ Time Frame: within the first seven weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581009 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Bipolar Disorder
  • Other: chronobiological 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
  • Drug: 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.

    Other Names:
    • Zoloft
    • Lithium
  • Radiation: one 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.
  • Experimental: 1
    chronobiological augmentation group
    Intervention: Other: chronobiological augmentation
  • Experimental: 2
    medication only group
    Intervention: Drug: sertraline, lithium
  • Experimental: MDD Mechanism
    Intervention: Radiation: one night of sleep deprivation and two FDG PET scans
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
January 2018
January 2018   (final data collection date for primary outcome measure)

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.

Exclusion Criteria:

Exclusion criteria include:

  1. Suicidality, or psychosis
  2. Unstable medical conditions
  3. Epilepsy, serious head injury, or other significant neurological disorders
  4. Dementia, mental retardation (moderate or severe), coma
  5. Prior exposure to radiation which might cause the subject to exceed standard guidelines
  6. Substance abuse or alcoholism in the past six months
  7. Unreliability or inability to adhere to the requirements of the study
  8. Irregular sleep-wake schedules (nightshift, jet lag)
  9. 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)
  10. Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders
  11. Donation or loss of blood (>400 ml) within the past month
  12. 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.
  13. Hamilton Rating Scale of Depression (HRSD-17 items)<17 unless subject is a normal control subject.
  14. Pregnancy or breast feeding
  15. 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.
  16. Unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to PET scans.
  17. Patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other SSRI's such as Paxil or Prozac
  18. Subjects with diagnosis of eating disorder/bulimia
Both
18 Years to 75 Years
Yes
Contact: Joseph C Wu, M.D. 949-824-7867 jcwu@uci.edu
United States
 
NCT00581009
HS#2001-1616
No
Joseph C. Wu, M. D. ,Associate Professor, Psychiatry, UCI-SOM, Clinical Director, Brain Imaging Center, University of California, Irvine
University of California, Irvine
University of California, San Diego
Study Chair: Barry F Chaitin, M.D. University of California, Irvine
University of California, Irvine
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP