Icalcaprant for Depression

Recruiting at 12 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Failed 3 antidepressants, Allergic reaction, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

195 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Icalcaprant for individuals with major depressive disorder (MDD) who are experiencing a major depressive episode (MDE). The trial aims to evaluate the treatment's effectiveness and potential side effects. Participants will be divided into three groups: two receiving different doses of Icalcaprant and one receiving a placebo (a pill with no medication). It is suitable for adults who have been experiencing depression for at least four weeks but less than six months. Participants must attend regular check-ups, including medical tests and questionnaires, over six weeks, with a follow-up after 30 days. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Icalcaprant is under study as a treatment for depression. Studies are examining its safety and effectiveness in reducing symptoms of major depressive disorder. Although detailed safety data for this specific trial is not yet available, earlier research on similar treatments suggests that Icalcaprant might be well-tolerated.

In past studies, Icalcaprant was generally safe for other mood disorders, such as bipolar disorder, indicating it might be similarly safe for depression. However, since this trial is in an early stage, researchers are closely examining its safety and possible side effects.

Participants in this trial will receive either one of two doses of Icalcaprant or a placebo. Regular check-ups will monitor any side effects, ensuring early detection of any issues. Those considering participation should know that the trial aims to learn more about the safety of Icalcaprant for treating depression. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Researchers are excited about Icalcaprant for depression because it represents a novel approach to treatment. Most current antidepressants, like SSRIs and SNRIs, work by altering serotonin and norepinephrine levels in the brain. Icalcaprant, however, targets the kappa opioid receptor, which is a different pathway altogether. This unique mechanism of action could offer relief for patients who haven't responded well to traditional treatments. Additionally, the potential for faster onset of action makes Icalcaprant a promising option in the field of mental health.

What evidence suggests that this trial's treatments could be effective for depression?

Research shows that Icalcaprant is being tested as a potential treatment for major depressive disorder (MDD) in this trial. Participants will receive either Icalcaprant Dose A, Icalcaprant Dose B, or a placebo. Studies have shown that people with MDD who didn't improve with standard treatments experienced symptom relief when using a drug similar to Icalcaprant. This drug targets specific receptors in the brain that influence mood and emotions. This is promising because about 30% of people with MDD don't respond to regular antidepressants. Although more research is needed, early results suggest Icalcaprant might benefit those who haven't found relief with other treatments. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with major depressive disorder currently in a depressive episode, lasting at least 4 weeks but not more than 6 months, can join this trial. They must have normal or non-significant abnormal physical exam results, lab tests, vital signs, and ECG readings. Their BMI should be between ≥18.0 to ≤35.0 kg/m2.

Inclusion Criteria

I have been diagnosed with major depression without psychosis.

My BMI is between 18.0 and 35.0.

I have been feeling very depressed for at least 4 weeks but no more than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral Icalcaprant or placebo once daily for 6 weeks

6 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Icalcaprant

Trial Overview

The study is testing Icalcaprant's effect on depression symptoms compared to a placebo (a pill without the active drug). Participants will randomly receive either Icalcaprant or placebo capsules daily for six weeks and undergo regular medical assessments and questionnaires.

How Is the Trial Designed?

Group I: Icalcaprant Dose B Experimental Treatment 1 Intervention

Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.

Group II: Icalcaprant Dose A Experimental Treatment 1 Intervention

Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.

Group III: Placebo for Icalcaprant Placebo Group 1 Intervention

Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38649428/

Efficacy and safety of aticaprant, a kappa receptor ...

In this study of participants with MDD and inadequate response to SSRI/SNRI, adjunctive treatment with aticaprant significantly reduced depressive symptoms ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07276997

A Study to Assess Change in Disease Activity and Adverse ...

This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive ...

3.

tipranks.com

tipranks.com/news/company-announcements/abbvie-advances-icalcaprant-trial-in-depression-what-investors-should-watch

AbbVie Advances Icalcaprant Trial in Depression

The aim is to see how well the oral drug Icalcaprant reduces symptoms of major depressive disorder and how safe it is over a short, six-week ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032724010863

Preclinical and clinical efficacy of kappa opioid receptor ...

Approximately 30 % of persons with Major Depressive Disorder (MDD) inadequately respond to conventional antidepressants. Kappa opioid receptor ( ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06696755

NCT06696755 | A Study to Assess Adverse Events and ...

This study will assess how safe and effective Icalcaprant is in treating adult participants with bipolar I or II disorder. Icalcaprant is an investigational ...