CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Lithium +2 moredrug
Likely dose
Lithium 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01431573
NCT01431573N/ACompleted

Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression

New York State Psychiatric Institute·interventional·Posted Sep 9, 2011·Updated Mar 18, 2021

In Brief

A clinical study evaluating Wake Therapy, light box, and 1 other intervention for Major Depressive Disorder and Bipolar Disorder. Completed, enrolled 8 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 14.8 years ago

Interventions

Wake Therapybehavioral

Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.

light boxdevice

use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire

Lithiumdrug

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)