ITI-1284 for Generalized Anxiety Disorder

Recruiting at 4 trial locations

Overseen By ITI Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Intra-Cellular Therapies, Inc.

Must be taking: Paroxetine, Venlafaxine XR, Duloxetine, Escitalopram, Buspirone

Disqualifiers: Schizophrenia, Bipolar, Suicidal risk, others

Stay on Your Current Meds You can continue your current medications while participating

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

2 Power Preferred Clinics 2 of this trial's clinics are considered top 20 on Power

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

705 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ITI-1284, to determine its effectiveness for people with generalized anxiety disorder (GAD) who haven't found relief from their current medication. Participants will receive either ITI-1284 or a placebo to compare the new treatment's efficacy. The study aims to assess the effectiveness, safety, and tolerability of ITI-1284. Individuals with moderate to severe GAD who haven't experienced significant improvement from their current medication might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from a new therapy.

Do I have to stop taking my current medications for the trial?

No, you do not have to stop taking your current medications. In fact, you must continue your current GAD-approved treatment at the same dose for the duration of the study.

Is there any evidence suggesting that ITI-1284 is likely to be safe for humans?

Research shows that ITI-1284 is a modified version of lumateperone, a drug already used for some mental health conditions. Researchers are studying this new version to determine its effectiveness for generalized anxiety disorder (GAD). Since ITI-1284 is related to lumateperone, which the FDA has approved for other uses, early signs suggest it might be safe for people.

Although detailed safety information for ITI-1284 in treating GAD isn't available yet, its progression to a Phase 2 trial indicates it has been deemed safe enough for further testing. Researchers carefully monitor these trials for any side effects or issues to ensure the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Generalized Anxiety Disorder, which often include SSRIs and benzodiazepines, ITI-1284 stands out with its novel mechanism of action. ITI-1284 is being explored for its potential to target anxiety through different pathways, possibly offering benefits such as faster onset of effects or reduced side effects compared to existing medications. Researchers are particularly excited about ITI-1284 because it could offer a new option for patients who do not respond well to current treatments, providing hope for improved management of anxiety symptoms.

What evidence suggests that ITI-1284 could be an effective treatment for generalized anxiety disorder?

Research shows that ITI-1284, a modified version of lumateperone, is under investigation in this trial for its potential to aid individuals with generalized anxiety disorder (GAD). Earlier studies have shown lumateperone's promise in treating disorders of the brain and nervous system, including GAD. The drug likely works by balancing brain chemicals, which could help reduce anxiety symptoms. Early results suggest it might be effective when added to standard GAD treatments, especially for those not fully benefiting from their current medication. While more research is needed, these initial findings offer hope for its potential benefits for GAD patients. Participants in this trial will receive either ITI-1284 at different dosages or a placebo to evaluate its effectiveness. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with Generalized Anxiety Disorder (GAD) who haven't had enough relief from their current treatment. Participants must meet the criteria for GAD as defined by a manual called DSM-5-TR.

Inclusion Criteria

Are you currently taking one of these treatments, and experiencing a poor response? Paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone.

Have you tried at least one of the following treatments that didn't work? Paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone.

Exclusion Criteria

Have you tried 4 or more of the following treatments that haven't worked? Paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone.

Have you been diagnosed with Schizophrenia?

Have you been diagnosed with Bipolar Disorder?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 3 weeks

Treatment

Participants are randomized to receive ITI-1284 10 mg, ITI-1284 20 mg, or placebo for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ITI-1284

Trial Overview The study tests ITI-1284 at two different doses (10 mg and 20 mg) against a placebo, to see if it can better help manage anxiety when added to existing treatments. It's conducted across multiple centers where patients are randomly assigned to one of the options in a blinded manner.

How Is the Trial Designed?

Group I: ITI-1284 20mg Experimental Treatment 1 Intervention

Group II: ITI-1284 10mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+

Published Research Related to This Trial

Duloxetine was found to be effective in reducing anxiety symptoms in elderly patients (aged 65 and older) with generalized anxiety disorder, showing significant improvements on various anxiety scales compared to placebo over a treatment period of 9-10 weeks.

However, the treatment was associated with a higher rate of adverse events, including nausea and weight loss, leading to a notable discontinuation rate of 22.2% among duloxetine-treated patients due to these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of duloxetine in elderly patients with generalized anxiety disorder: a pooled analysis of four randomized, double-blind, placebo-controlled studies. Davidson, J., Allgulander, C., Pollack, MH., et al.[2022]

Duloxetine is an FDA-approved medication for treating generalized anxiety disorder (GAD), supported by several double-blind, placebo-controlled clinical trials that demonstrate its efficacy in reducing anxiety symptoms.

The review of clinical studies and data from Eli Lilly provides valuable insights for physicians, helping them identify suitable patients for duloxetine treatment based on its pharmacologic profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine for the treatment of generalized anxiety disorder: a review. Khan, AY., Macaluso, M.[2021]

Buspirone, approved by the FDA in 1986 for generalized anxiety disorder (GAD), has been studied for its efficacy and safety in treating various conditions beyond anxiety, including panic disorder, major depressive disorder, and posttraumatic stress disorder.

While there are limited placebo-controlled trials for conditions other than GAD, the increasing research suggests promising future applications for buspirone in treating a wider range of mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buspirone: future directions. Apter, JT., Allen, LA.[2022]

In a study of 43 subjects with Generalized Anxiety Disorder, both escitalopram and duloxetine showed significant improvements in anxiety and depression scores over 6 months, with similar dropout rates.

Duloxetine demonstrated higher remission and response rates compared to escitalopram after the first month, particularly in the somatic symptoms of anxiety, suggesting it may be a more effective initial treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open, non-randomised comparison of escitalopram and duloxetine for the treatment of subjects with Generalized Anxiety Disorder. Pierò, A., Locati, E.[2022]

Duloxetine has been shown to be moderately effective in treating generalized anxiety disorder (GAD), with a significant improvement in response rates compared to placebo, as evidenced by a risk ratio of 1.48 from a meta-analysis of 7 studies involving 2,674 participants.

The medication also demonstrated significant superiority in remission rates and symptom reduction on the Hamilton Rating Scale for Anxiety, while its tolerability was comparable to that of placebo, indicating it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine in treating generalized anxiety disorder in adults: A meta-analysis of published randomized, double-blind, placebo-controlled trials. Zhang, Y., Huang, G., Yang, S., et al.[2017]

In a study of 44 patients with generalized anxiety disorder, buspirone was found to be more effective than placebo and comparable to lorazepam, a commonly used benzodiazepine, in reducing anxiety symptoms.

Buspirone was associated with fewer side effects than lorazepam and did not cause rebound anxiety or withdrawal symptoms, maintaining its anxiolytic effect for at least 2 weeks after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the efficacy of buspirone in patients affected by generalized anxiety disorder, shifting to buspirone from prior treatment with lorazepam: a placebo-controlled, double-blind study. Delle Chiaie, R., Pancheri, P., Casacchia, M., et al.[2019]

In a 5-week study involving 267 outpatients with Generalized Anxiety Disorder (GAD), ipsapirone at a dose of 5.0mg showed significant improvement in anxiety symptoms compared to placebo, as measured by multiple anxiety scales.

While ipsapirone demonstrated efficacy, higher doses (7.5mg) were associated with increased side effects like dizziness and nausea, which may reduce its effectiveness, suggesting that a moderate dose is optimal for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II multicenter dose-finding, efficacy and safety trial of ipsapirone in outpatients with generalized anxiety disorder. Cutler, NR., Hesselink, JM., Sramek, JJ.[2019]

Pregabalin, a gamma-aminobutyric acid analogue, has been shown to be generally well tolerated and effective for treating generalized anxiety disorder (GAD) in five double-blind, placebo-controlled trials, with a rapid onset of action around one week.

Compared to traditional treatments like benzodiazepines, pregabalin has similar efficacy but lower discontinuation rates, making it a promising option for GAD patients, particularly those with additional psychiatric or medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of generalized anxiety disorder with pregabalin, an atypical anxiolytic. Strawn, JR., Geracioti, TD.[2021]

In a 4-week study involving 271 patients, pregabalin 200 mg three times a day significantly reduced anxiety symptoms compared to placebo, with improvements seen as early as week 1.

Pregabalin was generally well-tolerated, with mild to moderate side effects like somnolence and dizziness, and a higher treatment completion rate compared to lorazepam, indicating its potential as a safe option for treating generalized anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, fixed-dose, multicenter study of pregabalin in patients with generalized anxiety disorder. Feltner, DE., Crockatt, JG., Dubovsky, SJ., et al.[2015]

In a study of 137 patients with generalized anxiety disorder (GAD), both buspirone dosing regimens (30 mg/day, either twice a day or three times a day) significantly reduced anxiety symptoms without notable differences in efficacy between the two schedules over 8 weeks.

The safety profile was similar for both treatment groups, although a higher incidence of amblyopia was observed in patients taking buspirone 15 mg twice a day, indicating that while buspirone is effective, monitoring for specific side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of two dosing regimens of buspirone in the treatment of outpatients with persistent anxiety. Sramek, JJ., Frackiewicz, EJ., Cutler, NR.[2019]

Citations

1. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/iti-1284-intra-cellular-therapies-generalized-anxiety-disorder-gad-likelihood-of-approval/

ITI-1284 by Intra-Cellular Therapies for Generalized ... ITI-1284 is under clinical development by Intra-Cellular Therapies and currently in Phase II for Generalized Anxiety Disorder (GAD).

2. delta.larvol.com delta.larvol.com/Products/?ProductId=3d84e631-13ef-4920-bf87-654358a4c962

lumateperone deuterated (ITI-1284 ODT-SL) / J&J We plan to initiate our program for the development of ITI-1284-ODT-SL for the treatment of behavioral disturbances in dementia in the second half of 2021.

3. sec.gov sec.gov/Archives/edgar/data/1567514/000162828025006993/itci-20241231.htm

itci-20241231 Our ITI-1284 program relates to a deuterated form of lumateperone for the treatment of generalized anxiety disorder, and other central nervous system disorders.

4. synapse.patsnap.com synapse.patsnap.com/drug/c3846763631f43ef99d80602aec99087

ITI-1284 - Drug Targets, Indications, Patents A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as an adjunctive treatment.

5. patientcareonline.com patientcareonline.com/view/lumateperone-for-mdd-update-j-j-acquires-intra-cellular-as-fda-snda-decision-approaches

Lumateperone for MDD Update: J&J Acquires Intra- ... The acquisition brings lumateperone, known as Caplyta, and the clinical-stage agent ITI-1284, for generalized anxiety disorder and Alzheimer's