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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581009
• Other study ID #: HS#2001-1616
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 30, 2001
• Est. completion date: December 9, 2011

Study information

• Verified date: January 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 9, 2011
• Est. primary completion date: December 9, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Sleep Deprivation

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Score for Depression		within the first seven weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy