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

Sponsor

University of California, Irvine (Other)

Overall Status

Completed

CT.gov ID

NCT00581009

Collaborator

University of California, San Diego (Other)

Enrollment

Locations

Arms

126.3

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Bipolar Disorder	Other: chronobiological augmentation Drug: sertraline, lithium Radiation: one night of sleep deprivation and two FDG PET scans	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 30, 2001

Actual Primary Completion Date :

Dec 9, 2011

Actual Study Completion Date :

Dec 9, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 chronobiological augmentation group	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
Experimental: 2 medication only group	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
Experimental: MDD Mechanism	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.

Arm

Intervention/Treatment

Experimental: 1

chronobiological augmentation group

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

Experimental: 2

medication only group

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

Experimental: MDD Mechanism

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.

Outcome Measures

Primary Outcome Measures

Hamilton Rating Score for Depression [within the first seven weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Inclusion criteria include:

Subjects must be English speaking
Subjects must have either bipolar or unipolar depression diagnosis or be a normal control.
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:

Suicidality, or psychosis
Unstable medical conditions
Epilepsy, serious head injury, or other significant neurological disorders
Dementia, mental retardation (moderate or severe), coma
Prior exposure to radiation which might cause the subject to exceed standard guidelines
Substance abuse or alcoholism in the past six months
Unreliability or inability to adhere to the requirements of the study
Irregular sleep-wake schedules (nightshift, jet lag)
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)
Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders
Donation or loss of blood (>400 ml) within the past month
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.
Hamilton Rating Scale of Depression (HRSD-17 items)<17 unless subject is a normal control subject.
Pregnancy or breast feeding
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.
Unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to PET scans.
Patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other SSRI's such as Paxil or Prozac
Subjects with diagnosis of eating disorder/bulimia