What is the mechanism of action of this treatment?

Common treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain. SSRIs block the reabsorption (reuptake) of serotonin into neurons, making more serotonin available to improve transmission of messages between neurons. SNRIs similarly block the reuptake of both serotonin and norepinephrine. Atypical antidepressants, such as bupropion, may affect the levels of dopamine and norepinephrine. These mechanisms are crucial because they help correct the chemical imbalances in the brain that are thought to contribute to depression, thereby alleviating symptoms and improving mood in patients.

What side effects are associated with this type of intervention?

Common treatments for depression, including SSRIs (e.g., sertraline, fluoxetine), SNRIs (e.g., venlafaxine, duloxetine), and atypical antidepressants (e.g., bupropion, mirtazapine), often have side effects such as nausea, headache, dizziness, dry mouth, insomnia, and sexual dysfunction. Augmentation strategies, such as adding antipsychotics (e.g., quetiapine, olanzapine), can lead to weight gain, metabolic changes, and increased risk of extrapyramidal symptoms. Newer treatments that modulate neurotransmitter levels may have similar side effects, including gastrointestinal disturbances, sleep issues, and cognitive effects like impaired concentration and confusion.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of depression that modulate neurotransmitter levels. Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, are commonly used. Tricyclic antidepressants (TCAs) like imipramine and amitriptyline have also been approved. More recently, atypical antidepressants such as bupropion and the NMDA receptor antagonist esketamine have been approved, offering additional options for patients with treatment-resistant depression.

What other types of research exist?

Promising novel alternatives to traditional antidepressant medications for depression patients in 2024 include: 1) Ketamine and other NMDA antagonists, which have shown rapid antidepressant effects; 2) Triple reuptake inhibitors, which target multiple neurotransmitters simultaneously; 3) Electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), which are non-pharmacological brain stimulation techniques; 4) mGluR2/3 antagonists, which have demonstrated rapid and lasting antidepressant effects in preclinical studies.

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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

Must not have

Renal and hepatic dysfunction with specific criteria

Patients with clinical significant hypotension or ECG abnormality at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 8 only

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney and liver functions are within specific limits.

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I have low blood pressure or abnormal heart rhythm issues.

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I am currently taking pramipexole or ondansetron.

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I have tried at least two antidepressants without success.

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I am not pregnant, breastfeeding, or on a low-estrogen contraceptive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 8 only

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tolerability will be assessed by the determination of a Maximum Tolerated Dose of pramipexole

Secondary study objectives

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain. SSRIs block the reabsorption (reuptake) of serotonin into neurons, making more serotonin available to improve transmission of messages between neurons. SNRIs similarly block the reuptake of both serotonin and norepinephrine. Atypical antidepressants, such as bupropion, may affect the levels of dopamine and norepinephrine. These mechanisms are crucial because they help correct the chemical imbalances in the brain that are thought to contribute to depression, thereby alleviating symptoms and improving mood in patients.