ITI-1284 for Generalized Anxiety Disorder

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

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.

What data supports the idea that the drug ITI-1284 for Generalized Anxiety Disorder is an effective treatment?

The available research does not provide specific data on the effectiveness of ITI-1284 for Generalized Anxiety Disorder. Instead, it focuses on other drugs like duloxetine, buspirone, ipsapirone, and pregabalin. These studies show that these drugs can be effective in treating Generalized Anxiety Disorder, with pregabalin having a rapid onset of action and being well-tolerated. However, there is no direct comparison or data available for ITI-1284 in the provided information. ^{1 2 3 4 5}

What safety data exists for ITI-1284 in treating Generalized Anxiety Disorder?

The provided research does not contain any safety data for ITI-1284, deuterated lumateperone, or ITI-1284-ODT-SL. The studies focus on other treatments such as duloxetine, pregabalin, and buspirone for Generalized Anxiety Disorder. ^{1 2 6 7 8}

Is the drug ITI-1284 a promising treatment for Generalized Anxiety Disorder?

The information provided does not include any details about ITI-1284, so we cannot determine if it is a promising treatment for Generalized Anxiety Disorder based on the given research articles. ^{4 7 8 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Duloxetine in treating generalized anxiety disorder in adults: A meta-analysis of published randomized, double-blind, placebo-controlled trials. [2017]

2. England 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. [2022]

3. United States 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. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, fixed-dose, multicenter study of pregabalin in patients with generalized anxiety disorder. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Buspirone: future directions. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

9. New Zealand pubmed.ncbi.nlm.nih.gov

Duloxetine for the treatment of generalized anxiety disorder: a review. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of two dosing regimens of buspirone in the treatment of outpatients with persistent anxiety. [2019]