N/A
N=8
Wake Therapy in the Treatment of Depression
Major Depressive Disorder · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01431573 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS) — 16.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wake Therapy (Behavioral); light box (Device); Lithium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS) |
16.6 | — |
| SECONDARY Morningness-Eveningness Questionnaire (MEQ), |
45.3 | — |
| SECONDARY Symptom Check List (SCL-90) |
1.03 | — |
| SECONDARY Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16) |
11.5 | — |
| SECONDARY Hypomania Interview Guide, Current Assessment Version (HIGH-C) |
2.0 | — |
| SECONDARY Clinical Global Improvement (CGI) |
3.25 | — |
Summary
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.
Eligibility Criteria
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 18-75
- 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
- cognitive dysfunction
- Parkinson's Disease
- Thyroid Stimulating Hormone > 5 milli International Units/Liter
- left ventricular hypertrophy
- symptomatic mitral valve prolapse
- abnormal creatinine
Data sourced from ClinicalTrials.gov (NCT01431573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.