Are you healthy and looking to help advance medical science?

You may be eligible to participate in a bipolar disorder clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a bipolar disorder clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Bipolar Disorder Clinical Trial

NCT00581009 | Phase 1 phase 2 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a bipolar disorder clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a bipolar disorder clinical study, and could be compensated for your time.

Unknown status

Male & Female

18 - 75

Years old

This study is looking to recruit 180 Participants

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.

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Details for the study

Brief Title

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

Official Title

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

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.

Treatments and/or Procedures

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.

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.

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

Study 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