Rachel Manber
TRIAD - Treatment of Insomnia and Depression
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: escitalopram
- Drug: sertraline
- Drug: desvenlafaxine
- Behavior: Insomnia Therapy
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
18 years to 75 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Meets criteria for Major Depressive Disorder
2. Between 18 and 75 years of age and adequately fluent in English
3. Meets criteria for an insomnia disorder
Key Exclusion Criteria:
1.Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
2. People for whom the antidepressant medication(s) provided in the study is not indicated
3. People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
5. People with uncontrolled medical conditions.
6. People with moderate or severe sleep disorders other than insomnia
7. Individuals on a fixed night shift or rotating work schedule that requires a night shift.
8. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
Additional Study Details
Official Title:
Improving Depression Outcome by Adding Insomnia Therapy to AntidepressantsAnticipated start date:
12/1/2008Lead Sponsor:
Stanford UniversityCollaborator(s):
- Duke University
- University of Pittsburgh
- University of Pennsylvania
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Rate of depression remission
Secondary Outcomes:
- Rate of Insomnia remission
Total Number to be Enrolled:
320Total Number to be Enrolled at Stanford:
85More Information
Secondary ID(s):
- MH78924
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
10/13/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help