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Not yet recruitingPhase 4

Lumateperone Added to Antidepressant Therapy in Adults With Major Depressive Disorder Experiencing Emotional Blunting

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Adults with Major Depressive Disorder who report blunted emotion that is evidenced by responses on the Oxford Depression Questionnaire will add lumateparone to their current treatment once daily for 8 weeks."
  • "Primary endpoint will be change fom baseline to week 8 on the Oxford Depression Questionnaire (ODQ)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding lumateperone to a current antidepressant can reduce or end emotional blunting, or feeling emotionally numb. It is for adults with major depressive disorder who have these feelings. The study uses the Oxford Depression Questionnaire to measure changes.

The purpose of this study is to evaluate whether or not adding lumateparone to current antidepressant treatment in adults with major depressive disorder experiencing blunted emotion will reduce or eliminate the blunted emotion as rated by the Oxford Depression Questionnaire.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have major depressive disorder listed in your medical record and confirmed by the lead study doctor using a mental health interview.
  • Score above 50 on the Oxford Depression Questionnaire, showing strong emotional blunting.
  • Answer yes to a screening question about feeling emotionally numb, having fewer positive or negative feelings, feeling disconnected, or caring less about things during the past 6 weeks.

Who can't join

  • Currently take antipsychotic medicines.
  • Currently take medicines that block CYP3A4, a substance in the body that helps break down medicines.
  • Currently use cannabis.
  • Have moderate to severe liver problems.
  • Have a main diagnosis other than major depressive disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Diagnosis of major depressive disorder documented in the medical record and confirmed through evaluation by the Principal Investigator using the M.I.N.I., Oxford Depression Questionnaire score of \> 50 (substantial emotional blunting), Response of "yes" to the "gold standard" standardized screening question on emotional blunting developed by Price et al(2012): "Emotional effects vary, but may include, for example, feelingemotionally 'numbed' or 'blunted' in some way; lacking positive emotions or negative emotions; feeling detached from the world around you; or 'just not caring' about things you used to care about. Have you experienced such emotional effects during the last 6 weeks?" - Exclusion Criteria: Concomitant antipsychotics, Concomitant inhibitors of CYP3A4, Concomitant use of cannabis, Moderate to severe hepatic impairment, Primary diagnosis other than major depressive disorder \-

Study sites (1)

PA