CTC-501 for Depression

Recruiting in Palo Alto (17 mi)

Overseen byMark Leibowitz, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Chase Therapeutics Corporation

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests pramipexole and ondansetron in patients with major depressive disorder. Pramipexole aims to improve mood by affecting brain chemicals, and ondansetron helps prevent nausea. Pramipexole has been tested in various studies for its efficacy in treating major depression, while ondansetron is being explored for its potential benefits in combination with other treatments. The study compares the treatment over a few months.

Eligibility Criteria

This study is for men and women aged 18-65 with major depressive disorder (MDD), who score above a certain level on the HAM-D depression scale. Participants must not be on antidepressants or agree to stop them before starting the trial, and can't start new psychotherapies during the trial. Pregnant or breastfeeding women, those with significant liver or kidney issues, drug abuse history, serious suicidal risk, or certain other health conditions are excluded.

Inclusion Criteria

I have been diagnosed with major depressive disorder.

I have been diagnosed with major depression without psychosis.

I agree not to start new mental health therapies during the trial, but can continue if already started 3+ months ago.

+4 more

Exclusion Criteria

My kidney and liver functions are within specific limits.

Lifetime history of certain mental health disorders

History of serious suicidal attempt or tendencies

+10 more

Participant Groups

The clinical trial is testing CTC-501 in patients with MDD. It's a Phase 2a study where participants will either receive this experimental medication or a placebo without knowing which one they're getting (single-blind). The goal is to see if CTC-501 helps improve symptoms of depression compared to no active treatment.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: treatmentExperimental Treatment1 Intervention

CTC-501 (pramipexole IR, given with ondansetron) given orally twice daily

Group II: placeboPlacebo Group1 Intervention

generic placebo tablets given orally twice daily