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NCT05061719CompletedPhase 3

An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Source: ClinicalTrials.gov · Last updated 3 Nov 2025

Brief summary (registry, in English)

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
812 (actual)
First submitted
20 Sept 2021
Start date
8 Oct 2021
Primary completion date
14 Oct 2024
Lead sponsor
Intra-Cellular Therapies, Inc.
Diseases
Depression
NCT number
NCT05061719

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 812
  • From 8 Oct 2021 to the primary completion date, 14 Oct 2024
  • 94 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.

Other

  • In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
  • In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
    • At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
    • At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).

Who the study is looking for

  • In the opinion of the Investigator, patients must have safely completed the lead-in study.
  • Patient is taking their ADT as prescribed from the lead-in study.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (94)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BurgasBulgariaUnknown status
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KazanlakBulgariaUnknown status
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Novi IskarBulgariaUnknown status
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PlevenBulgariaUnknown status
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PlovdivBulgariaUnknown status
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RousseBulgariaUnknown status
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SofiaBulgariaUnknown status
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TargovishteBulgariaUnknown status
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Tsarev BrodBulgariaUnknown status
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Veliko TarnovoBulgariaUnknown status
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VratsaBulgariaUnknown status
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BrnoCzechiaUnknown status
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HostiviceCzechiaUnknown status
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OstravaCzechiaUnknown status
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PilsenCzechiaUnknown status
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PragueCzechiaUnknown status
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Bad HomburgGermanyUnknown status
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Freiburg im BreisgauGermanyUnknown status
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HamburgGermanyUnknown status
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MittweidaGermanyUnknown status
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SchwerinGermanyUnknown status
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WesterstedeGermanyUnknown status
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HelsinkiFinlandUnknown status
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OuluFinlandUnknown status
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BudapestHungaryUnknown status
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DebrecenHungaryUnknown status
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GyöngyösHungaryUnknown status
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AhmedabadIndiaUnknown status
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Chhatrapati SambhajinagarIndiaUnknown status
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GuwahatiIndiaUnknown status
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JūnāgadhIndiaUnknown status
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MumbaiIndiaUnknown status
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MysoreIndiaUnknown status
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NagpurIndiaUnknown status
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NashikIndiaUnknown status
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VadodaraIndiaUnknown status
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Ansan-siSouth KoreaUnknown status
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GwangjuSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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BełchatówPolandUnknown status
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BialystokPolandUnknown status
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BydgoszczPolandUnknown status
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GdanskPolandUnknown status
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GorlicePolandUnknown status
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LesznoPolandUnknown status
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Pruszcz GdańskiPolandUnknown status
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TorunPolandUnknown status
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WroclawPolandUnknown status
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LundSwedenUnknown status
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StockholmSwedenUnknown status
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BratislavaSlovakiaUnknown status
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KošiceSlovakiaUnknown status
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Rimavská SobotaSlovakiaUnknown status
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SvidníkSlovakiaUnknown status
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Vranov nad TopľouSlovakiaUnknown status
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Zlaté MoravceSlovakiaUnknown status
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AllentownUnited StatesUnknown status
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AtlantaUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BellevueUnited StatesUnknown status
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BentonvilleUnited StatesUnknown status
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BerlinUnited StatesUnknown status
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BostonUnited StatesUnknown status
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BrooklynUnited StatesUnknown status
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CedarhurstUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
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Culver CityUnited StatesUnknown status
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DecaturUnited StatesUnknown status
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FlowoodUnited StatesUnknown status
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Fort LauderdaleUnited StatesUnknown status
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GaithersburgUnited StatesUnknown status
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GlendaleUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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JolietUnited StatesUnknown status
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Little RockUnited StatesUnknown status
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MediaUnited StatesUnknown status
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Mount KiscoUnited StatesUnknown status
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Newport BeachUnited StatesUnknown status
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OceansideUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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Overland ParkUnited StatesUnknown status
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Palm BayUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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Plymouth MeetingUnited StatesUnknown status
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RedlandsUnited StatesUnknown status
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RiversideUnited StatesUnknown status
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RogersUnited StatesUnknown status
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Saint CharlesUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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Sherman OaksUnited StatesUnknown status
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TemeculaUnited StatesUnknown status
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Toms RiverUnited StatesUnknown status
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UplandUnited StatesUnknown status
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West Palm BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.