Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

• Between 18 and 65 years old

• Current major depressive episode

• Habitual TIB of 7 to < 10 hours

• No antidepressant medications for ≥ 2 weeks (4 weeks for MAOIs or longer acting antidepressants)

• Score of at least 18 on the Hamilton Rating Scale of Depression

Exclusion Criteria:

• Alcohol or substance abuse/dependence in past 6 months

• Current posttraumatic stress disorder or bulimia nervosa (past 6 months)

• Lifetime history of bipolar I or II disorder, schizophrenia/other psychotic disorder, and anorexia nervosa

• Trials of fluoxetine in the past 6 months

• Medical disorders or pain syndromes that may affect sleep or are associated with significant depression (e.g. thyroid or Cushing's disease); history of head trauma with loss of consciousness of > 5 minutes; history of seizures

• Sleep disorders other than insomnia, such as sleep apnea and periodic limb movement disorder

• Current use of prescription, over-the-counter, or naturopathic remedies for sleep (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics) or depression (e.g., Sam-E, St. John's Wort)

• Currently working evening or midnight shift (subjects who have recently traveled across multiple time zones will be included at the discretion of the PI).

• Currently at risk for drowsy driving or employment that requires routine operation of transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous equipment.

• Known allergy, hypersensitivity or contraindication to study medication

• Females: pregnant or nursing