What side effects are associated with this type of intervention?

Common treatments for depression include SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), tricyclic antidepressants (e.g., amitriptyline), and atypical antidepressants (e.g., bupropion, mirtazapine). Known side effects of SSRIs and SNRIs include nausea, insomnia, sexual dysfunction, and increased anxiety. Tricyclic antidepressants can cause dry mouth, constipation, urinary retention, and orthostatic hypotension. Atypical antidepressants may lead to weight gain, sedation, and, in the case of bupropion, an increased risk of seizures. It is important to discuss these potential side effects with a healthcare provider to tailor treatment to individual needs.

What prior FDA approvals exist?

The FDA has approved several classes of medications for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine and venlafaxine, and atypical antidepressants like bupropion and mirtazapine. Additionally, tricyclic antidepressants (TCAs) such as imipramine and monoamine oxidase inhibitors (MAOIs) like phenelzine have also been approved. These medications work through various mechanisms, including the modulation of neurotransmitters like serotonin, norepinephrine, and dopamine, to alleviate depressive symptoms.

What other types of research exist?

Promising novel alternatives to NBI-1065845 for depression treatment include INN 00835, a synthetic pentapeptide with potential for rapid onset of action, and LY341495, which produces rapid and long-lasting reversal of anhedonia caused by chronic stress. Both agents show potential for rapid antidepressant effects, which is a desirable characteristic in new treatments.

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NBI-1065845 for Depression (SAVITRI Trial)

Phase 2

Waitlist Available

Research Sponsored by Neurocrine Biosciences

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called NBI-1065845 to see if it can help people with Major Depressive Disorder (MDD) feel better. The goal is to find out if NBI-1065845 can reduce symptoms of depression.

Who is the study for?

Adults aged 18-65 with Major Depressive Disorder (MDD) who haven't had enough improvement from previous antidepressant treatments can join. They must be on a stable depression medication for at least 8 weeks or have taken it for that long in their current episode. Pregnant or breastfeeding individuals, those with unstable health conditions, certain psychiatric disorders other than MDD, or a history of substance abuse cannot participate.

What is being tested?

The trial is testing the effectiveness of NBI-1065845 versus a placebo in improving symptoms of depression in adults with MDD. Participants will either receive the experimental drug NBI-1065845 or a placebo to compare outcomes between the two groups.

What are the potential side effects?

While specific side effects are not listed here, participants may experience adverse reactions related to NBI-1065845 compared to those taking the placebo. Side effects could range from mild to severe and will be monitored throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: NBI-1065845 Low DoseExperimental Treatment1 Intervention

Participants will receive low-dose NBI-1065845 orally once a day.

Group II: NBI-1065845 High DoseExperimental Treatment1 Intervention

Participants will receive high-dose NBI-1065845 orally once a day.

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo orally once a day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NBI-1065845

2022

Completed Phase 2

~190

Do I qualify?Apply below to find out

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 primarily involve medications that modulate neurotransmitter levels in the brain. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) increase the levels of serotonin and norepinephrine by inhibiting their reuptake into neurons. Tricyclic antidepressants (TCAs) also block the reuptake of these neurotransmitters but have a broader mechanism affecting other neurotransmitter systems. Monoamine oxidase inhibitors (MAOIs) prevent the breakdown of monoamine neurotransmitters, increasing their availability. Novel treatments like ketamine act on the glutamatergic system, providing rapid antidepressant effects. Understanding these mechanisms is crucial for patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.

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