Suvorexant for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Suvorexant is safe and manageable for veterans with Major Depressive Disorder and a high risk of suicide. Typically used for sleep issues, Suvorexant is being tested to determine if it can alleviate depression symptoms when taken daily for four weeks. Veterans with a history of depression and suicide attempts might find this trial suitable. Participants must visit the medical center three times during the trial and complete remote assessments. As a Phase 2 trial, this research measures Suvorexant's effectiveness in an initial, smaller group, offering veterans a chance to contribute to important findings.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot participate if you are using certain medications like strong CYP3A liver enzymes, moderate CYP3A inhibitors, strong CYP3A inducers, or digoxin.
Is there any evidence suggesting that Suvorexant is likely to be safe for humans?
Research has shown that suvorexant, an FDA-approved medication for treating insomnia, is generally safe for most people. In one study involving individuals with mental health conditions, only 12.2% experienced side effects. Another study found that only 3% of participants discontinued suvorexant due to side effects. These findings suggest that most people can use suvorexant without major issues. Although this trial tests it for a different condition, the medication has demonstrated a good overall safety record.12345
Why do researchers think this study treatment might be promising for depression?
Most treatments for depression, like SSRIs and SNRIs, work by altering serotonin or norepinephrine levels in the brain. But Suvorexant works differently, targeting the orexin system, which plays a role in regulating sleep and mood. Researchers are excited because Suvorexant, originally approved for insomnia, might help with depression, especially for those at high risk of suicide, by improving sleep quality and potentially lifting mood. This unique mechanism offers hope for faster and possibly more effective relief for patients who haven't responded well to traditional antidepressants.
What evidence suggests that Suvorexant might be an effective treatment for Major Depressive Disorder?
Research suggests that Suvorexant, initially approved for insomnia, might also alleviate symptoms of Major Depressive Disorder (MDD). One study found that Suvorexant improved depression symptoms in individuals with MDD. This medication blocks certain brain chemicals that promote wakefulness, which may also enhance mood and reduce depression. Although the results are promising, further research is necessary to confirm its effectiveness, particularly for MDD with a higher risk of suicide. Participants in this trial will receive Suvorexant to further explore its potential benefits for MDD.12678
Are You a Good Fit for This Trial?
This trial is for veteran adults with Major Depressive Disorder and a high risk of suicide. Participants will take the drug Suvorexant daily for four weeks, with in-person visits at weeks 1, 3, and 5, plus remote self-reports at weeks 2 and 4.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take Suvorexant daily for four weeks, starting with 10mg for the first two weeks and 20mg for the last two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Suvorexant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marianne Goodman
Lead Sponsor
Marianne Goodman
Lead Sponsor
VISN 2 Mental Illness Research & Education Clinical Center
Collaborator
James J. Peters Veterans Affairs Medical Center
Collaborator