> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/study-of-iti-1284-as-an-adjunctive-treatment-in-patients-ff765d2d-f930-4033-ad59-e7eed48635d5
> Record changed: 2026-10-13

# Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder

NCT06480383

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

Participants

705

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

Lead sponsor

Intra-Cellular Therapies, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

Start date

2024-08-05

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

Number of sites

56

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Title and summary

**Summary**

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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Short title**

Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Official title**

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Dates

**Completion date**

2027-03-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**First posted**

2024-06-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Registry last updated**

2026-08-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Primary completion date**

2027-03-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Start date**

2024-08-05

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Size and sites

**Participants**

705

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Planned participants**

705

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Number of sites**

56

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Lead sponsor**

Intra-Cellular Therapies, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Identifiers

**Registry ID**

NCT06480383

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**ClinicalTrials.gov ID**

NCT06480383

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Triple masking

**Masked roles**

Participants, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Outcomes

### Primary outcomes

1. Hamilton Anxiety Rating Scale (HAM-A)  
Timeframe: Week 6  
The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It comprises of 14 items that are rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 with a higher score indicating increased severity of anxiety symptoms.

### Secondary outcomes

1. Clinical Global Impression Scale-Severity (CGI-S)  
Timeframe: Week 6  
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Eligibility

**Sex**

All

**Age groups**

Children, Adults, Older adults

**Healthy volunteers**

No

### Inclusion criteria

1. Provide written informed consent before the initiation of any study specific procedures;
2. Male or female patients ≥ 18 years of age;
3. At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:

  1. HAM-A Total score of ≥ 22;
  2. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
  3. CGI-S score of ≥ 4;
4. 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 a minimum total daily dose of paroxetine 20 milligrams \[mg\], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;
5. 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 a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) 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.

### Exclusion criteria

1. Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:

  1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
  2. Bipolar Disorder;
2. MADRS total score > 18 at Screening or Baseline;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or

  1. At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
  2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
  3. At Screening or Baseline MADRS Item 10 score ≥ 5; or
  4. The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator.
4. 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 (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks).

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Sites

- Behavioral Research Specialists LLCGlendale, United StatesRecruiting
- Sun Valley Research CenterImperial, United StatesRecruiting
- Synergy EastLemon Grove, United StatesRecruiting
- Excell Research IncOceanside, United StatesRecruiting
- NRC Research InstituteOrange, United StatesRecruiting
- Anderson Clinical ResearchRedlands, United StatesRecruiting
- Premier Clinical ResearchMiami, United StatesRecruiting
- Global Medical InstitutesMiami, United StatesRecruiting
- Miami Dade Medical Research InstituteMiami, United StatesRecruiting
- Sunshine Medical SolutionMiami, United StatesRecruiting
- South Florida Research IncMiami Springs, United StatesRecruiting
- K2 Medical ResearchTampa, United StatesRecruiting
- CenExeli Research LLCAtlanta, United StatesRecruiting
- Atlanta Center for Medical ResearchAtlanta, United StatesRecruiting
- Michigan Clinical Research InstituteAnn Arbor, United StatesRecruiting
- Bio Behavioral HealthToms River, United StatesRecruiting
- SPRI Clinical Trials, LLCBrooklyn, United StatesRecruiting
- Neuro Behavioral Clinical ResearchNorth Canton, United StatesRecruiting
- Sooner Clinical ResearchOklahoma City, United StatesRecruiting
- Lehigh Center for Clinical Research LLCAllentown, United StatesRecruiting
- Suburban Research AssociatesMedia, United StatesRecruiting
- Austin Clinical Trial PartnersAustin, United StatesRecruiting
- BioBehavioral Research of Austin PCAustin, United StatesRecruiting
- Aims Trials LLCPlano, United StatesRecruiting
- Northwest Clinical Research CenterBellevue, United StatesRecruiting

And 31 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## References

### Other registry identifiers

- 2024-513302-56-00

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480383)

## Related records

### Drugs (2)

- [Diazepam](https://trialight.com/data/asset/diazepam-a0cb3123-d888-4bf4-b90a-171c1dcecccb.md)
- [Zinc sulfate](https://trialight.com/data/asset/zinc-sulfate-89916c92-5761-48ff-8b38-fe26bc5f899c.md)

### Lead sponsors (1)

- [Intra-Cellular Therapies, Inc.](https://trialight.com/data/company/intra-cellular-therapies-inc-ccd80b85-eef2-442b-8c93-d3e15f2eb816.md)

### Conditions (1)

- [Generalized anxiety disorder](https://trialight.com/data/condition/generalized-anxiety-disorder-06f2f230-65ba-5929-af6a-36d14f38281d.md) Primary condition

### Targets (16)

- [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md)
- [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md)
- [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md)
- [GABRA4](https://trialight.com/data/target/gabra4-8db035f5-598b-561c-bccf-339883590a0d.md)
- [GABRA5](https://trialight.com/data/target/gabra5-b7313ea4-035e-5ccf-8477-4e09fa235563.md)
- [GABRA6](https://trialight.com/data/target/gabra6-217bacdc-dfe0-5560-a2f5-7921b78e7abf.md)
- [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md)
- [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md)
- [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md)
- [GABRD](https://trialight.com/data/target/gabrd-9320aad1-3e84-5d9b-9702-43d3de2273dc.md)
- [GABRE](https://trialight.com/data/target/gabre-38203809-e856-5ed9-b0df-ad994e506211.md)
- [GABRG1](https://trialight.com/data/target/gabrg1-9fce5825-56bf-57ff-b57f-213bcd9cc866.md)
- [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md)
- [GABRG3](https://trialight.com/data/target/gabrg3-e56da4b8-b4dd-5273-ac25-9cb3b1e98de6.md)
- [GABRP](https://trialight.com/data/target/gabrp-1815637f-6695-5cdf-917f-29b7c1596d44.md)
- [GABRQ](https://trialight.com/data/target/gabrq-441cdc7f-1c46-5673-9300-cc381ae42f30.md)

---

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