ITI-1284 for Generalized anxiety disorder

Inclusion criteria

• {"criterion_text":"- Provide written informed consent before the initiation of any study specific procedures; NOTE: Patients who are unable to provide informed consent on their own, including those that are under guardianship or curatorship, will be ineligible to participate in this study.\n- Male or female patients ≥ 18 years of age\n- Has a body mass index (BMI) of 19-40 kg/m2 , inclusive\n- At Screening (Visit 1), meet DSM-5-TR diagnostic criteria for moderate or severe Generalized Anxiety Disorder as confirmed by the Investigator or Sponsor-approved rater using the SCID-5-CT, and meets all of the following at Screening (Visit 1) and Baseline (Visit 2): a. HAM-A Total score of ≥ 22; b. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2; c. CGI-S score of ≥ 4; d. At Baseline (Visit 2) ≤ 25% improvement in HAM-A total score from that at Screening (Visit 1)\n- History of inadequate response (< 50% improvement in anxiety symptoms as measured by the modified ATRQ for GAD) to at least 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least the minimum GAD-approved dose per package insert) and duration (ie, for at least 6 weeks prior to Screening [Visit 1]) for the treatment of ongoing GAD symptoms\n- Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study\n- Male or female of childbearing potential and agrees to use a highly effective method of birth control (defined as those methods, alone or in combination, which result in a failure rate less than 1 percent per year when used consistently and correctly as listed in Appendix II), from the time informed consent is provided through the end of the SFU period. Abstinence may be an acceptable form of birth control based on the Investigator’s judgment and familiarity with the patient’s “preferred and usual lifestyle”; NOTE: Females of non-childbearing potential (defined as either permanently sterilized) or post-menopausal females (defined as at least one year with no menses without an alternative medical explanation) are exempt from the birth control requirement. As per Investigator’s judgment, females with exclusively same sex partners are also exempt from the birth control requirement.\n- Ability to follow study instructions and likely to complete all required visits.\n- Applicable to Czech Republic Only: Patient has a caregiver who is willing to sign the patient information leaflet (informed consent form) and is familiar with the circumstances of the patient’s participation in the clinical trial and able to monitor their compliance and safety during their contact at least 5 times a week."}

Exclusion criteria

• {"criterion_text":"- Within the patient’s lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; b. Bipolar Disorder\n- Within 6 months of Screening (Visit 1), has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. Other anxiety disorders (except simple phobias and social anxiety disorder); b. Moderate or severe alcohol or substance use disorders (excluding nicotine); c. Moderate or severe major depressive disorder (MDD); d. Any other psychiatric condition (except for mild MDD) that has been the main focus of treatment or of sufficient severity to have a major impact on the patient’s psychiatric status\n- MADRS total score > 18 at Screening (Visit 1) or Baseline (Visit 2)\n- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or a. At Screening (Visit 1), the patient scores “yes” on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening (Visit 1) or, at Baseline (Visit 2), the patient scores “yes” on Suicidal Ideation Items 4 or 5 since the screening visit; b. At Screening (Visit 1), the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; c. At Screening (Visit 1) or Baseline (Visit 2) MADRS Item 10 score ≥ 5; or d. The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator\n- Lifetime history of failure to respond to > 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (ie, at least the minimum dose approved for GAD per package insert) and for an adequate duration (ie, at least 6 weeks)\n- The patient has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans-cranial magnetic stimulation within the last 2 years prior to Screening (Visit 1), or had a failure in response to ECT at any time\n- The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients\n- The patient has plans to initiate psychotherapy during the study; ongoing psychotherapy that has been stable (at least 2 months) prior to Baseline (Visit 2) is permissible\n- The patient is unable to be safely discontinued or unwilling to discontinue benzodiazepine treatment at least 2 days prior to Baseline (Visit 2)\n- The patient has used 1 of the following agents under the specified conditions: a. Any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor or any CYP3A4 inducer within 5 half-lives or 14 days prior to Baseline (Visit 2); b. Monoamine oxidase inhibitors within 14 days prior to Baseline (Visit 2)\n- The patient is unable to be safely discontinued or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, in the opinion of the Investigator, before Baseline (Visit 2), including, but not limited to: a. Sedative hypnotics; b. Central opioid agonists/antagonists including tramadol; c. Anticonvulsants, mood stabilizers, antidepressants, stimulants, antipsychotics, and nonbenzodiazepine anxiolytics\n- Please refer to the Protocol for additional exclusion criteria."}

Primary endpoints

• {"endpoint_text":"- The primary efficacy endpoint is the change from baseline to end of Week 6 in HAM-A total score.","definition_or_measurement_approach":"Change from baseline to end of Week 6 measured using the Hamilton Anxiety Rating Scale (HAM-A) total score."}

Secondary endpoints

• {"endpoint_text":"- The key secondary efficacy endpoint is the change from baseline to end of Week 6 in CGI-S score.","definition_or_measurement_approach":"Change from baseline to end of Week 6 measured using the Clinical Global Impression-Severity (CGI-S) score."}
• {"endpoint_text":"- by visit, change from baseline in HAM-A total score","definition_or_measurement_approach":"Visit-by-visit change from baseline in HAM-A total score (Hamilton Anxiety Rating Scale)."}
• {"endpoint_text":"- CGI-S score","definition_or_measurement_approach":"Clinical Global Impression-Severity (CGI-S) score measured at scheduled visits."}
• {"endpoint_text":"- Q-LES-Q score","definition_or_measurement_approach":"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score measured at scheduled visits."}
• {"endpoint_text":"- ≥ 50% reduction from baseline in HAM-A total score","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction from baseline in HAM-A total score."}
• {"endpoint_text":"- HAM-A remission (HAM-A total score ≤ 7)","definition_or_measurement_approach":"Proportion of participants with HAM-A total score ≤7 (remission) at assessment visits."}
• {"endpoint_text":"- CGI-I scale score","definition_or_measurement_approach":"Clinical Global Impression-Improvement (CGI-I) scale score assessed at visits."}
• {"endpoint_text":"- change from baseline in MADRS total score","definition_or_measurement_approach":"Change from baseline in Montgomery–Åsberg Depression Rating Scale (MADRS) total score."}
• {"endpoint_text":"- PGI-C scale score","definition_or_measurement_approach":"Patient Global Impression of Change (PGI-C) scale score measured at visits."}

Methods

• K1_Recruitment arrangements (documented) — recruitment arrangements document present (country-specific versions exist) describing overall recruitment approach.
• Online advertising (K2_Recruitment material_Online Advertising Script) — digital ads/online recruitment scripts (country-specific versions present for multiple Member States).
• Posters (K2_Recruitment material_Poster / Poster-11x17) — physical poster materials for site display (country-specific versions present).
• Recruiting brochure (K2_Recruitment material_Recruiting Brochure) — printed brochure for potential participants (country-specific versions present).
• Patient letter (K2_Recruitment material_Patient Letter) — invitation/letter sent to potential participants (country-specific versions present).
• Physician referral letter (K2_Recruitment material_Physician Referral Letter) — materials to facilitate referral from clinicians (country-specific versions present).
• Appointment reminder card and Thank You card (K2_Recruitment material_Appointment Reminder Card; K2_Recruitment material_Thank You Card) — site-level participant materials to support retention.

Poland

Earliest CTIS Part Ii Submission Date

05-05-2025

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

105

Number Of Sites

6

Number Of Participants

61

Bulgaria

Earliest CTIS Part Ii Submission Date

22-04-2025

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

114

Number Of Sites

10

Number Of Participants

108

Czechia

Earliest CTIS Part Ii Submission Date

22-10-2025

Latest Decision Or Authorization Date

19-11-2025

Processing Time Days

28

Number Of Sites

7

Number Of Participants

84

Slovakia

Earliest CTIS Part Ii Submission Date

21-05-2025

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

359

Number Of Sites

4

Number Of Participants

48

Finland

Earliest CTIS Part Ii Submission Date

21-10-2025

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

206

Number Of Sites

4

Number Of Participants

48

Primary sponsor

Full Name

Intra-Cellular Therapies Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Worldwide Clinical Trials d.o.o.

Responsibilities

codes: 1, 12, 13, 2, 5, 6

Name

PPD Development LP

Responsibilities

codes: 4

Name

Propharma Group LLC

Responsibilities

codes: 8

Name

Catalent Germany Schorndorf GmbH

Responsibilities

codes: 14

Name

Iqvia Laboratories Limited

Responsibilities

codes: 4

Name

Medidata Solutions Inc.

Responsibilities

codes: 3, 7

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 3, 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Croatia","full_name":"Worldwide Clinical Trials d.o.o.","duties_or_roles":"codes: 1, 12, 13, 2, 5, 6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"codes: 4","organisation_type":"Non-Pharmaceutical company"}