What side effects are associated with this type of intervention?

Common treatments for depression include SSRIs (e.g., fluoxetine, sertraline), which can cause side effects like nausea, insomnia, sexual dysfunction, and weight gain. SNRIs (e.g., venlafaxine, duloxetine) may lead to similar side effects along with increased blood pressure. Tricyclic antidepressants (e.g., amitriptyline, imipramine) often cause dry mouth, constipation, urinary retention, and orthostatic hypotension. Atypical antidepressants (e.g., bupropion, mirtazapine) can result in insomnia, weight gain, and dry mouth. These side effects vary in intensity and occurrence among individuals.

What other types of research exist?

Promising novel alternatives for depression treatment in 2024 include psilocybin-assisted psychotherapy, which has shown sustained reductions in depressive symptoms, and pramipexole, a dopamine agonist with potential antidepressant effects. Additionally, MDMA-assisted psychotherapy is being explored for its efficacy in treatment-resistant depression.

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Ropanicant for Depression

Q: What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of depression. Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, are commonly used. Atypical antidepressants like bupropion and mirtazapine offer alternative mechanisms of action. Additionally, augmentation strategies with atypical antipsychotics like aripiprazole have been approved for treatment-resistant depression. These treatments provide a range of options for managing depressive symptoms.

Phase 2

Waitlist Available

Research Sponsored by Suven Life Sciences Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits.

Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening to day 21

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called ropanicant to see if it can help people with moderate to severe depression. The study will involve 36 participants who will take different doses of the medication for a short period.

Who is the study for?

This trial is for individuals with moderate to severe Major Depressive Disorder (MDD) who have been feeling depressed for at least 4 weeks. They should score high on depression severity scales and meet specific diagnostic criteria without having psychotic features.

What is being tested?

The study is testing the safety and effectiveness of a medication called Ropanicant in treating MDD. It's an open-label, parallel-group study, meaning participants know they're receiving Ropanicant and are compared with others in separate groups.

What are the potential side effects?

While the side effects of Ropanicant are not detailed here, similar medications often cause nausea, headaches, dizziness, sleep disturbances or changes in appetite. Participants will be monitored for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is considered moderately severe or worse.

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I have been diagnosed with major depression without psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening to day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening to day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to day 21 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary study objectives

Montgomery-Åsberg Depression Rating Scale (MADRS) score.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Ropanicant 45 mg qdExperimental Treatment1 Intervention

The participant will take 1 tablet/day in the morning (for qd dosing)

Group II: Ropanicant 45 mg bidExperimental Treatment1 Intervention

The participant will take 2 tablets/day (\~12 hours apart for bid dosing).

Group III: Ropanicant 30 mg bidExperimental Treatment1 Intervention

The participant will take 2 tablets/day (\~12 hours apart for bid dosing).

0 / 2Eligibility 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 include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which work by increasing the levels of neurotransmitters serotonin and norepinephrine in the brain, respectively. Atypical antidepressants like bupropion and mirtazapine act on different neurotransmitter systems, such as dopamine and norepinephrine, or block specific serotonin receptors. Understanding these mechanisms is crucial for patients because it helps tailor treatment plans to individual needs, manage side effects, and improve overall treatment outcomes. For instance, if a patient does not respond to one class of antidepressants, switching to another class with a different mechanism of action may be more effective.

Dogs bark, but the caravan goes on: A discussion on the meta-analysis of antidepressants by Andrea Cipriani et al.Bulimia nervosa : a review of therapy research.Comparative studies on the efficacy of psychotherapy, pharmacotherapy, and their combination in depression: was adequate pharmacotherapy provided?