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 Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to at least 1 GAD-approved treatment (ie, one 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, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;\n- Currently having an inadequate response to one 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]) and agrees to continue the same dosing regimen for the duration of the study; NOTE: The current GAD approved treatment must be different from the GAD treatment identified as the historical failure.\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), 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\n- Ability to follow study instructions and likely to complete all required visits"}

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 12 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.\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, or had a failure in response to ECT at any time;\n- The patient has known hypersensitivity or intolerance to ITI-1284, or to any of the 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 taking more than 1 ADT or is taking ADT + buspirone at Screening (Visit 1), regardless of indication, and is unable or unwilling to discontinue additional ADT (or buspirone) prior to Baseline (Visit 2); NOTE: Patients are required to be currently on a GAD-approved treatment at Screening (Visit 1) and Baseline (Visit 2)\n- At Screening (Visit 1), the patient has been taking benzodiazepines > 3 times per week for > 6 weeks;\n- The patient is unable 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 or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee, before Baseline (Visit 2)\n- Please see the Protocol for additional exclusion criteria."}

Primary endpoints

• {"endpoint_text":"- Primary efficacy endpoint is change from baseline to Week 6 in HAM-A total score.","definition_or_measurement_approach":"Change from baseline to end of Week 6 in Hamilton Anxiety Rating Scale (HAM-A) total score (as stated in main objective: measured by change from baseline to end of Week 6 in HAM-A total score)."}

Secondary endpoints

• {"endpoint_text":"- Key secondary efficacy endpoint is change from baseline to Week 6 in CGI-S score.","definition_or_measurement_approach":"Change from baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) score."}
• {"endpoint_text":"- Additional secondary efficacy endpoints may include by visit: change from baseline in HAM-A total score; CGI-S score; or Q-LES-Q score; ≥ 50% reduction from baseline in HAM-A total score; HAM-A remission (HAM-A total score ≤ 7); CGI-I scale score; change from baseline in MADRS total score; PGI-C scale score","definition_or_measurement_approach":"Multiple measures by visit including change from baseline in HAM-A total score, CGI-S, Q-LES-Q, proportion with ≥50% HAM-A reduction, HAM-A remission (≤7), CGI-I, change in MADRS total score, and PGI-C as listed in the secondary endpoint description."}

Methods

• K1_Recruitment arrangements (public) — recruitment arrangements documents present (country-specific documents available for BG, FI, PL).
• K2_Recruitment material_Recruiting brochure (Finland) — recruiting brochure listed for Finland.
• K2_Recruitment material_Online advertising script (Finland) — online advertising script listed for Finland.
• K2_Recruitment material_Physician Letter (Bulgaria) — physician letter listed (Bulgaria).

Czechia

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

288

Number Of Sites

5

Number Of Participants

60

Finland

Earliest CTIS Part Ii Submission Date

04-12-2025

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

13

Number Of Sites

4

Number Of Participants

36

Bulgaria

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

10-09-2025

Processing Time Days

293

Number Of Sites

13

Number Of Participants

144

Poland

Earliest CTIS Part Ii Submission Date

20-11-2024

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

370

Number Of Sites

6

Number Of Participants

72

Primary sponsor

Full Name

Intra-Cellular Therapies Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

sponsorDuties codes: 4; contact email: Janel.Conti@ppdi.com

Name

Propharma Group LLC

Responsibilities

sponsorDuties codes: 8; contact email: submissions@propharmagroup.com

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties codes: 3,7; contact email: info@medidata.com

Third parties

• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 4 (as listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"sponsorDuties codes: 8 (as listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 3,7 (as listed)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"sponsorDuties codes: 14 (as listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: 4 (as listed)","organisation_type":"Non-Pharmaceutical company"}