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

NCT ID: NCT00581009

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-30
• Study Completion Date: 2011-12-09

Brief 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.

Conditions

Major Depressive Disorder; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronobiological augmentation

chronobiological augmentation group

Group Type: EXPERIMENTAL

chronobiological augmentation

Intervention Type: OTHER

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

Medication only

medication only group

Group Type: EXPERIMENTAL

sertraline, lithium

Intervention Type: DRUG

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.

MDD Mechanism

Group Type: EXPERIMENTAL

one night of sleep deprivation and two FDG PET scans

Intervention Type: RADIATION

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

Zoloft; Lithium

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Joseph Wu

Professor of Psychiatry & Human Behavior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry F Chaitin, M.D.

Role: STUDY_CHAIR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

University of California, San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

20011616

Identifier Type: -

Identifier Source: org_study_id