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CTC-501 for Depression

Phase 2
Waitlist Available
Led By Mark Leibowitz, MD
Research Sponsored by Chase Therapeutics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females with a diagnosis of major depressive disorder
Meet DSM-V R criteria for major depression, single episode or recurrent episode, with or without melancholia and without psychotic features
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8 only
Awards & highlights

Study Summary

This trial is testing whether an experimental drug is effective and safe for people with major depressive disorder.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for CTC-501 aren't listed here, common side effects of medications tested for depression may include nausea, headache, sleep disturbances, agitation, sexual dysfunction and sometimes more severe risks like increased suicidal thoughts especially in younger individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depressive disorder.
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I have been diagnosed with major depression without psychosis.
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I am between 18 and 65 years old.
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My depression is severe, based on recent test scores.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8 only
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8 only for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tolerability will be assessed by the determination of a Maximum Tolerated Dose of pramipexole
Secondary outcome measures
Clinical Global Impression - Improvement scale
Clinical Global Impression - Severity scale
Pharmacokinetics will measure plasma concentrations of pramipexole and ondansetron
+2 more

Trial Design

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

Find a Location

Who is running the clinical trial?

Chase Therapeutics CorporationLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Mark Leibowitz, MDPrincipal InvestigatorCollaborative Neuroscience Network
4 Previous Clinical Trials
78 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a patient fulfill to be eligible for this medical experiment?

"This research endeavour is searching for 24 eligible candidates aged between 18 and 65 to participate. To gain entry, prospective participants must have a diagnosis of depression."

Answered by AI

Has the FDA sanctioned CTC-501 for therapeutic use?

"Our assessment of CTC-501's safety was a score of 2, denoting that there is some available data indicating its security but no evidence of the treatment being efficacious."

Answered by AI

Does this research study admit participants aged 55 and over?

"This medical trial has an age restriction, with the lower limit set at 18 and the upper limit set to 65."

Answered by AI

Is recruitment for this study currently open?

"The details on clinicaltrials.gov implies that this medical experiment is not actively recruiting at the moment, with its first posting dating back to September 10th 2018 and last update being recorded as April 22nd 2022. Nevertheless, there are 1296 other research initiatives presently seeking participants."

Answered by AI

Who else is applying?

What site did they apply to?
Collaborative Neuroscience Network
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study in Patients With Major Depressive Disorder
2018. "A Study in Patients With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03642964.
All > Mdd
~3 spots leftby Dec 2024
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