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Icalcaprant · 4 trials · 4 indications
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study
Montgomery-Åsberg Depression Rating Scale (MADRS) The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are to be rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
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| Arm | Type | Description |
|---|---|---|
| Group 1: Icalcaprant Dose A | EXPERIMENTAL | Participants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks. |
| Group 2: Icalcaprant Dose B | EXPERIMENTAL | Participants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks. |
| Group 3: Placebo for Icalcaprant | PLACEBO_COMPARATOR | Participants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks. |
| Icalcaprant Dose A | EXPERIMENTAL | Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Icalcaprant Dose B | EXPERIMENTAL | Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Placebo for Icalcaprant | PLACEBO_COMPARATOR | Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Group 1: Icalcaprant Dose A- Japanese Participants | EXPERIMENTAL | Participants will receive oral Icalcaprant dose A once, then a 30-day follow-up period. |
| Group 2: Icalcaprant Dose A- Han Chinese Participants | EXPERIMENTAL | Participants will receive oral Icalcaprant dose A once, then a 30-day follow-up period. |
| Icalcaprant with Itraconazole | EXPERIMENTAL | Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days. |
| Name | Type | Description |
|---|---|---|
| Icalcaprant | DRUG | Oral Capsules |
| Placebo for Icalcaprant | DRUG | Oral Capsules |
| Itraconazole (ITZ) | DRUG | Oral capsule |
Inclusion Criteria: * Participants with a diagnosis of bipolar I or II according to the DSM-5-TR without psychotic features, confirmed by the MINI 7.0.2, and currently experiencing an MDE beginning at least 4 weeks prior to consent and not exceeding 12 months prior to Screening. * Body Mass Index (...
Icalcaprant is an investigational oral small molecule being studied in psychiatry for the treatment of Bipolar I Disorder, Bipolar II Disorder, and Major Depressive Disorder. It is also being evaluated in healthy volunteer studies to assess how the drug moves through the body. It is currently in Phase 2 clinical development.
Icalcaprant is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials of Icalcaprant in the United States for psychiatric conditions including bipolar disorder and major depressive disorder.
Icalcaprant is in Phase 2 clinical development for Bipolar I Disorder, Bipolar II Disorder, and Major Depressive Disorder. It has also completed Phase 1 studies in healthy volunteers. The drug is investigational and not yet approved by regulatory authorities.
Icalcaprant is being studied in a Phase 2 trial (NCT06696755) enrolling 195 adults with Bipolar I or II Disorder, and a Phase 2 trial (NCT07276997) enrolling 195 adults with Major Depressive Disorder. Both are recruiting in the United States. Completed Phase 1 trials include NCT06722417 and NCT06722430 in healthy volunteers.
Yes, Icalcaprant has been studied in healthy volunteers in two completed Phase 1 trials. NCT06722417 evaluated a single oral dose in healthy Japanese and Han Chinese adults, and NCT06722430 assessed how Icalcaprant moves through the body when given with itraconazole. Both trials were conducted in the United States.
Icalcaprant is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for bipolar disorder and major depressive disorder. The drug has not completed the clinical development process required for regulatory approval.