A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia

Depression Clinical Trial

Official title:

A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02669030
• Other study ID #: SVX-IIT2016-001
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Institute for Advanced Medical Research, Alpharetta, GA
• Contact: Brandon Lenfest, BS
• Phone: 770-817-9200
• Email: info[@]iamresearch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Depression with ongoing insomnia is a common clinical presentation with patients. Clinical data suggests that patients with insomnia that receive concomitant treatment with a sleep aid experience a more robust antidepressant response along with a quicker response. The purpose of this clinical study is to compare the effectiveness of the FDA-approved insomnia medication suvorexant, also known as Belsomra®, as add-on treatment to an antidepressant to that of placebo plus antidepressant treatment in patients with depression and residual or ongoing insomnia.

Description:

Many patients with depression suffer from residual insomnia. This study is a six week, randomized, double-blind, placebo-controlled, trial to study suvorexant augmentation of continuing antidepressant therapy against placebo with continuing antidepressant therapy. Patient volunteers must be on a stable antidepressant treatment and will remain on this treatment for the duration of the study. Patient volunteers that qualify and enroll in the clinical trial will either receive suvorexant 10 mg/day and may have it adjusted to a dose of either 15 mg or 20 mg/day. Treatment is for a total of six weeks in addition to a clinical follow-up visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Provide written Informed Consent

• Diagnosis of depression (MDD)

• Currently on antidepressant

• Healthy and/or stable medically

Exclusion Criteria:

• unwilling to discontinue current use of sedative hypnotics/sleep aids/benzodiazepines or over the counter sleep aids/supplements

• currently using other psychotropics other than antidepressants

• at risk of self harm or a suicide attempt within the past 12 months

• history or presence of psychotic disorders

• known hypersensitivity to suvorexant

• presence of any other sleep disorder other than residual insomnia of depression

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Insomnia
• Major Depressive Disorder
• MDD
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• suvorexant
an FDA-approved sleep aid
• Placebo
control group

Locations

Country	Name	City	State
United States	Institute for Advanced Medical Research @ Mercer Univeristy	Atlanta	Georgia
United States	Medical College of GA at Augusta Univeristy	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Advanced Medical Research, Alpharetta, GA	Augusta University, Dept. of Psychiatry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time	assessment of total amount of time spent sleeping	Six weeks ( baseline to end of treatment)
Secondary	Insomnia Severity Index (ISI)	assessment of insomnia severity	Six weeks ( baseline to end of treatment)
Secondary	Hamilton Depression Rating Scale	assessment fo depressive symptom severity	Six weeks ( baseline to end of treatment)
Secondary	Sheehan Disability Scale	assessment of impact of symptoms on performance	Six weeks ( baseline to end of treatment)
Secondary	Wake After Sleep Onset (WASO)	assessment of amount of time spent awake after initial onset of sleep	Six weeks ( baseline to end of treatment)
Secondary	Sleep Latency (SL)	assessment of amount of time it takes to fall asleep	Six weeks ( baseline to end of treatment)
Secondary	Perceived Deficits Questionnaire (PDQ)	a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression	Six weeks ( baseline to end of treatment)