Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2014 by University of Pittsburgh
Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
Dorothy Sit, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00852592
First received: February 25, 2009
Last updated: January 24, 2014
Last verified: January 2014
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Purpose
The purpose of this study is to understand the efficacy of light therapy for bipolar depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Major Depressive Episode |
Device: active light therapy unit Device: Inactive light therapy unit |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Continuous depression ratings on the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) instrument [ Time Frame: Weekly measures in the Acute Phase Weeks 1-6 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active Comparator
active light unit
|
Device: active light therapy unit
dosage - 15-60minutes NOON-2PM daily
|
|
Placebo Comparator: Inactive Comparator
inactive light unit
|
Device: Inactive light therapy unit
dosage: 15-60minutes NOON-2PM daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ages 18-65 years
- DSM-IV Criteria BD I or II depressive episode,
- SIGH-ADS >20; duration >2 weeks.
- Stable dose antidepressant drug >8 weeks with concurrent antimanic drug
- Controlled thyroid disease
- Subjects with preexisting eye diseases will be included.
- Able to provide informed consent
- Stable minimum dose antimanic drug >4weeks: lithium 0.5 mEq/L, divalproex Na 50 mcg/mL, olanzapine 5mg daily, carbamazepine 4mg/L; lamotrigine 100mg daily, risperidone 2mg daily, quetiapine 400 mg daily, ziprasidone 10 mg bid, and aripiprazole 5 mg qd.
- Stable unchanged psychotherapy for >16weeks
Exclusion Criteria:
- The following eye diseases: retinal disease, cataract surgery and lens removal, macular degeneration,
- Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
- Acute psychosis (DSM-IV Criteria)
- Rapid cycling in the past 1 year
- Obsessive compulsive disorder
- Alcohol or substance abuse or dependence in the past 6 months.
- MRS>5
- Recent history of a suicide attempt (3 months) or active suicidal Ideation (SIGHADS item H11 >2)
- Beta-adrenergic blockers, exogenous melatonin, chronic NSAIDS
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: NCT00852592
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852592
Contacts
| Contact: Dorothy Sit, M.D. | 412-246-5248 | sitdk@upmc.edu |
Locations
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Jonathan Weingarden, B.S. 412-246-5346 weingardenj@upmc.edu | |
| Contact: Dorothy Sit, M.D. 412-246-5248 sitdk@upmc.edu | |
| Principal Investigator: Dorothy Sit, M.D. | |
| University of Pittsburgh, Western Psychiatric Institute and Clinic | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Dorothy Sit, M.D. 800-436-2461 sitdk@upmc.edu | |
| Contact: Dorothy Sit 412-246-5248 sitdk@upmc.edu | |
| Principal Investigator: Dorothy Sit, M.D. | |
Sponsors and Collaborators
University of Pittsburgh
Investigators
| Principal Investigator: | Dorothy K Sit, M.D. | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Dorothy Sit, Assistant Professor of Psychiatry, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00852592 History of Changes |
| Other Study ID Numbers: | PRO09020546, NIMH# 1 K23 MH082114-01A2 |
| Study First Received: | February 25, 2009 |
| Last Updated: | January 24, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Bipolar Disorder Depression Midday Light Therapy Bipolar Disorder Type I or II |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mental Disorders Mood Disorders |
ClinicalTrials.gov processed this record on March 03, 2015