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



Status:Recruiting
Conditions:Depression, Insomnia Sleep Studies, Major Depression Disorder (MDD), Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:4/2/2016
Start Date:March 2001
End Date:January 2018
Contact:Joseph C Wu, M.D.
Email:jcwu@uci.edu
Phone:949-824-7867

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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.


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
We found this trial at
2
sites
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Irvine, CA
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