Actively Recruiting
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Led by Intra-Cellular Therapies, Inc. · Updated on 2025-07-01
470
Participants Needed
60
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
CONDITIONS
Official Title
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients between 18 and 65 years of age, inclusive
- Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria, including MDD with psychotic features
- Current major depressive episode started at least 12 weeks and no more than 18 months before screening
- Moderate severity of illness with MADRS score of 24 or higher at screening and baseline
- Moderate severity of illness with CGI-S score of 4 or higher at screening and baseline
- QIDS-SR-16 score of 14 or higher at screening and baseline
- Documented history confirming ongoing antidepressant treatment causing significant distress or impairment
- Inadequate response (less than 50% improvement) to at least two antidepressant treatments during current episode
- Currently taking minimum effective dose of one approved antidepressant monotherapy for at least 6 weeks
You will not qualify if you...
- Lifetime diagnosis of psychiatric disorders other than MDD, such as schizophrenia, schizoaffective disorder, schizophreniform disorder, or other psychotic disorders
- Lifetime diagnosis of bipolar disorder
- Diagnosis within 6 months of screening of anxiety disorders as primary diagnosis, including panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, or posttraumatic stress disorder
- Diagnosis within 6 months of screening of eating disorders
- Diagnosis within 6 months of screening of substance use disorders (excluding nicotine)
- Personality disorder significantly impacting psychiatric status
- Any other psychiatric condition (other than MDD) as main focus of treatment within 12 months of screening
- Decrease of 25% or more in MADRS or QIDS-SR-16 scores between screening and baseline
- Significant risk for suicidal behavior, including recent suicidal ideation or attempts
- First major depressive episode starting at age 60 years or older
AI-Screening
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Trial Site Locations
Total: 60 locations
1
Clinical Site
Huntsville, Alabama, United States, 35801
Actively Recruiting
2
Clinical Site
Pico Rivera, California, United States, 90660
Actively Recruiting
3
Clinical Site
Farmington, Connecticut, United States, 06030
Actively Recruiting
4
Clinical Site
Clermont, Florida, United States, 34711
Actively Recruiting
5
Clinical Site
Hialeah, Florida, United States, 33012
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6
Clinical Site
Miami, Florida, United States, 33122
Actively Recruiting
7
Clinical Site
Miami, Florida, United States, 33137
Actively Recruiting
8
Clinical Site
Miami, Florida, United States, 33180
Not Yet Recruiting
9
Clinical Site
Tampa, Florida, United States, 33629
Actively Recruiting
10
Clinical Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
11
Clinical Site
Decatur, Georgia, United States, 30030
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12
Clinical Site
Kansas City, Kansas, United States, 66103
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13
Clinical Site
Kansas City, Kansas, United States, 66160
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14
Clinical Site
Overland Park, Kansas, United States, 66210
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15
Clinical Site
Methuen, Massachusetts, United States, 01844
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16
Clinical Site
O'Fallon, Missouri, United States, 63368
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17
Clinical Site
New York, New York, United States, 10036
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18
Clinical Site
Avon Lake, Ohio, United States, 44012
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19
Clinical Site
Cincinnati, Ohio, United States, 45219
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20
Clinical Site
Columbus, Ohio, United States, 43210
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21
Clinical Site
Philadelphia, Pennsylvania, United States, 19104
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22
Clinical Site
Houston, Texas, United States, 77081
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23
Clinical Site
Richardson, Texas, United States, 75080
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24
Clinical Site
Bellevue, Washington, United States, 98007
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25
Clinical Site
Cherven Bryag, Bulgaria, 5980
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26
Clinical Site
Kardzhali, Bulgaria, 6600
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27
Clinical Site
Pleven, Bulgaria, 5800
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28
Clinical Site
Sofia, Bulgaria, 1202
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29
Clinical Site
Sofia, Bulgaria, 1431
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30
Clinical Site
Sofia, Bulgaria, 1510
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31
Clincal Site
Stara Zagora, Bulgaria, 6000
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32
Clinical Site
Varna, Bulgaria, 9020
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33
Clinical Site
Douai, France, 59500
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34
Clinical Site
Nantes, France, 44093
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35
Clinical Site
Nîmes, France, 30029
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36
Clinical Site
Paris, France, 75013
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37
Clinical Site
Poitiers, France, 86021
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38
Clinical Site
Ahmedabad, Gujarat, India, 380009
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39
Clinical Site
Ahmedabad, Gujarat, India, 38008
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40
Clinical Site
Rajkot, Gujarat, India, 360001
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41
Clinical Site
Surat, Gujarat, India, 394315
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42
Clinical Site
Kolhāpur, Maharahstra, India, 416001
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43
Clinical Site
Bārāmati, Maharashtra, India, 413102
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44
Clinical Site
Nagpur, Maharashtra, India, 440001
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45
Clinical Site
Pune, Maharashtra, India, 411011
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46
Clinical Site
Wardha, Maharashtra, India, 442004
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47
Clinical Site
Ajmer, Rajasthan, India, 305001
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48
Clinical Site
Kaunas, Lithuania, 44279
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49
Clinical Site
Ziegzdriai, Lithuania, 53136
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50
Clinical Site
Belgrade, Serbia, 11000
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51
Clinical Site
Gornja Toponica, Serbia, 18202
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52
Clinical Site
Kovin, Serbia, 26220
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53
Clinical Site
Kragujevac, Serbia, 34000
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54
Clinical Site
Niš, Serbia, 18000
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55
Clinical Site
Novi Kneževac, Serbia, 23330
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56
Clinical Site
Barcelona, Spain, 08035
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57
Clinical Site
Barcelona, Spain, 08036
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58
Clinical Site
Madrid, Spain, 28034
Actively Recruiting
59
Clinical Site
Sabadell, Spain, 08208
Actively Recruiting
60
Clinical Site
Zamora, Spain, 49021
Actively Recruiting
Research Team
I
ITI Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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