Wake Therapy in the Treatment of Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by New York State Psychiatric Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01431573
First received: August 12, 2011
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

This pilot study seeks to replicate previous findings that sleep deprivation results in marked improvement in depression symptoms, as well as to test whether concurrent treatment with Light Therapy and Lithium are successful in locking in and maintaining therapeutic effects in both bipolar and unipolar depressed subjects.


Condition Intervention
Major Depressive Disorder
Bipolar Disorder
Behavioral: Wake Therapy
Device: lightbox
Drug: Lithium Carbonate
Drug: Armodafinil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Structured Interview for the Hamilton Depression Scale with Atypical Depression Supplement(SIGH-ADS) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    This is a structured interview to obtain Hamilton Depression Rating Scale ratings, with additional items added to measure reverse vegetative features common in bipolar depression and depression with atypical features


Secondary Outcome Measures:
  • Morningness-Eveningness Questionnaire (MEQ), [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    This is a standard self-report instrument for measuring the extent to which an individual is an "early bird" vs. a "night owl," asking a variety of questions concerning the time of day individuals prefer engagement in various activities. Scores correlate highly with biologic measures of circadian rhythm phase and will be used to custom program the timing of each patient's light therapy and habitual sleep

  • Symptom Check List (SCL-90) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    This a standard listing covering most major categories of psychiatric symptoms. It allows measurement not only of depressive symptoms over time, but also other common symptoms, such as those of panic attacks or other anxiety disorders

  • Quick Inventory of Depressive Symptoms, Self rated (QIDS-SR 16) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    The responses to this question set, adapted from John Rush's Inventory of Depressive Symptoms, show high correlation with the original instrument

  • Hypomania Interview Guide, Current assessment version(HIGH-C) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: Yes ]
    The HIGH-C is structured like the SIGH-ADS, and provides assessments of manic and hypomanic symptoms , in order to help identify and quantify switches and mixed states.

  • Clinical Global Improvement (CGI) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    This is a standard measure of the clinician's overall impression of how the patient is doing. It includes two measurements, one for the patient's severity of overall symptomatology, and the other for improvement since starting treatment.


Estimated Enrollment: 10
Study Start Date: July 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wake Therapy + bright lights +/- lithium
  • Bipolar patients must take lithium; others do not take lithium
  • all patients are hospitalized for a week during which they do not sleep on alternating nights
  • for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations
Behavioral: Wake Therapy
Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.
Other Name: Wake Therapy
Device: lightbox
use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire
Other Name: Day Light
Drug: Lithium Carbonate
For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)
Other Name: Lithobid
Drug: Armodafinil
Armodafinil (Nuvigil®) 150 mg once or twice daily will be offered to patients to help maintain wakefulness. If excessive sleepiness remains, 250 mg will be offered with the option of a second dose of 150 mg 15 hours later (but not within 15 hours of intended sleep). Patients having experience with armodafinil will be offered the dose suggested by their prior experience.
Other Name: Nuvigil

Detailed Description:

Both refractory depression and bipolar depression are difficult to treat. A night of complete sleep deprivation has been shown to result in marked improvement in 60% of depressed patients, although maintenance of therapeutic effects have not been sustained with wake therapy alone. This pilot study will assess the effectiveness of wake therapy in treating both bipolar depression (5 participants)and major depression (5 participants), as well as the effectiveness of concomitant light therapy and lithium in maintaining the therapeutic effects. Participants will undergo direct observation in the hospital for one week during initial treatment with alternating nights of sleep deprivation, light therapy and lithium treatment, and then will be seen weekly as outpatients for 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. current major depressive episode(MDD, BP-I or BP-II)
  2. if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms
  3. If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate
  4. physically healthy
  5. age 18-60
  6. not taking current antidepressants(antidepressants deemed effective will not be discontinued

Exclusion Criteria:

  1. medically unstable condition
  2. past intolerance of lithium (bipolar only)
  3. history of (or current) psychosis or epilepsy
  4. current (past six months) drug or alcohol abuse/dependence
  5. pregnancy
  6. contraindication to lithium (bipolar only)
  7. significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration)
  8. currently taking effective antidepressant
  9. baseline HAMD > 40
  10. cognitive dysfunction
  11. Parkinson's Disease
  12. TSH > 5 mIU/L
  13. left ventricular hypertrophy
  14. symptomatic mitral valve prolapse
  15. abnormal creatinine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431573

Contacts
Contact: Vito Agosti, MSW 212-543-5605 agostiv@nypsi.columbia.edu
Contact: Brittany Anderson, BA 212-543-5734 banders@nyspi.columbia.edu

Locations
United States, New York
Depression Evaluation Service - New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Jonathan W. Stewart, M.D.    212-543-5745    jws6@columbia.edu   
Contact: Patrick J. McGrath, M.D.    (212) 543 5764    mcgrath@pi.cpmc.columbia.edu   
Principal Investigator: Jonathan W. Stewart, M.D.         
Sub-Investigator: Patrick J. McGrath, M.D.         
Sub-Investigator: Michael Terman, Ph.D.         
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Vito Agosti, MSW    212-543-5605    agostiv@nyspi.columbia.edu   
Contact: Brittany Anderson, BA    212-543-5734    banders@nyspi.columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Jonathan Stewart, M.D. New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01431573     History of Changes
Other Study ID Numbers: 5491, IRB 5491
Study First Received: August 12, 2011
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Armodafinil
Lithium
Lithium Carbonate
Modafinil
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 20, 2014