The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
Information source: University of California, Irvine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Bipolar Disorder
Intervention: chronobiological augmentation (Other); sertraline, lithium (Drug); one night of sleep deprivation and two FDG PET scans (Radiation)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: University of California, Irvine Official(s) and/or principal investigator(s):
Barry F Chaitin, M.D., Study Chair, Affiliation: University of California, Irvine
Overall contact:
Joseph C Wu, M.D., Phone: 949-824-7867, Email: jcwu@uci.edu
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.
Clinical Details
Official title: The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Hamilton Rating Score for Depression
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Joseph C Wu, M.D., Phone: 949-824-7867, Email: jcwu@uci.edu
University of California, Irvine, Irvine, California 92697, United States; Recruiting
Joseph C Wu, M.D., Phone: 949-824-7867, Email: jcwu@uci.edu
William E Bunney, Jr., M.D., Sub-Investigator
Steven Potkin, M.D., Sub-Investigator
Jody Rawles, M.D., Sub-Investigator
Charles Nguyen, M.D., Sub-Investigator
Marquis Vawter, Ph.D., Sub-Investigator
Marcel Hungs, M.D., Sub-Investigator
University of California, San Diego, La Jolla, California 92093 - 0603, United States; Recruiting
John R Kelsoe, M.D., Phone: 858-534-5927, Email: jkelsoe@ucsd.edu
John R Kelsoe, M.D., Principal Investigator
Additional Information
Starting date: March 2001
Ending date: January 2018
Last updated: May 12, 2009
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