Wake Therapy in the Treatment of Depression
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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 |
- 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
- 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
|
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 |
Inclusion Criteria:
- current major depressive episode(MDD, BP-I or BP-II)
- if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms
- If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate
- physically healthy
- age 18-60
- not taking current antidepressants(antidepressants deemed effective will not be discontinued
Exclusion Criteria:
- medically unstable condition
- past intolerance of lithium (bipolar only)
- history of (or current) psychosis or epilepsy
- current (past six months) drug or alcohol abuse/dependence
- pregnancy
- contraindication to lithium (bipolar only)
- significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration)
- currently taking effective antidepressant
- baseline HAMD > 40
- cognitive dysfunction
- Parkinson's Disease
- TSH > 5 mIU/L
- left ventricular hypertrophy
- symptomatic mitral valve prolapse
- abnormal creatinine
Contacts and Locations| Contact: Vito Agosti, MSW | 212-543-5605 | agostiv@nypsi.columbia.edu |
| Contact: Brittany Anderson, BA | 212-543-5734 | banders@nyspi.columbia.edu |
| 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 | |
| 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 Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Lithium Lithium Carbonate Modafinil Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Antidepressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 22, 2013