CLINICAL TRIAL

Seltorexant for Psychosis, Involutional

Recruiting · 18+ · All Sexes · Bojnice, Slovakia

This study is evaluating whether a drug may help improve depression symptoms in individuals who have not responded to other medications.

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About the trial for Psychosis, Involutional

Eligible Conditions
Depressive Disorder · Depression · Depressive Disorder, Major

Treatment Groups

This trial involves 2 different treatments. Seltorexant is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Matching placebo to Seltorexant
DRUG
Seltorexant
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Quetiapine XR
DRUG
Matching placebo to Quetiapine XR
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seltorexant
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Psychosis, Involutional or one of the other 2 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Have a patient version insomnia severity index (ISI) total score >= 15 as well as a clinician version of the ISI total score >= 15 at the second screening visit
Is receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at or above therapeutic dose level) for at least 6 weeks, and for no greater than 18 months in the current episode
Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60. The length of the current depressive episode must be less than or equal to (<=) 24 months
Body mass index (BMI) between 18 and 40 kilogram per meter square (kg/m^2), inclusive (BMI=weight/height^2)
Have a hamilton depression rating scale (HDRS)-17 total score greater than or equal to (>=) 20 at the first screening interview, must not demonstrate a clinically significant improvement (that is, an improvement of > 20% on their HDRS-17 total score) from the first to the second independent HDRS-17 rating, and must have a HDRS-17 total score >18 at the second screening interview
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 26
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 26.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Seltorexant will improve 1 primary outcome and 9 secondary outcomes in patients with Psychosis, Involutional. Measurement will happen over the course of Baseline to Week 26.

Change from Baseline in MADRS-6 Total Score
BASELINE TO WEEK 26
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
BASELINE TO WEEK 26
MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score
BASELINE TO WEEK 26
The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.
Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score
BASELINE TO WEEK 26
The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders-5th edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Change from baseline in Weight up to Week 26
BASELINE TO WEEK 26
Change from baseline in weight will be reported.
Time to Study Drug Discontinuation for Potentially Treatment Related Reasons
UP TO WEEK 26
Time to discontinuation of study drug for potentially treatment related reasons will be reported. Potentially treatment related reasons are defined as all study drug discontinuations excluding the potentially non-treatment related discontinuations (eg, loss of insurance for antidepressant therapy, movement/travel out of the area, change of work-schedule being unable to accommodate visit schedule, family circumstances).
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is psychosis, involutional?

Data from a recent study provides evidence that the psychopathology of psychosis or brain morphology in people with schizophrenia has to be integrated in order to understand the complexity of this disorder.

Anonymous Patient Answer

What are common treatments for psychosis, involutional?

Treatment for involutional psychosis is not well defined. The most common recommended treatment is olanzapine, a medication often used for schizophrenia. One limitation of this study is that the sample is not geographically representative, because participants had to take an online survey rather than being interviewed in-person about their experiences with the disease being studied. Another limitation is the small sample size. The small sample size and the study being retrospective have made finding statistically valid answers harder. However, the use of online questionnaires allows for a more representative sampling of opinions.

Anonymous Patient Answer

What causes psychosis, involutional?

Although psychosis can be induced in test animals with the'stress hormone' dexamethasone, it is difficult to demonstrate in test animals that psychosis is a 'psychosis'. We do not now possess the pharmacological techniques required to study psychosis with test animals. But we do know that it is related to brain-to-brain and CNS-to-cognitive (thinking) communication. In fact, the brain's dysfunction with schizophrenia may be the very root cause of the disease.

Anonymous Patient Answer

How many people get psychosis, involutional a year in the United States?

About 690,000 people develop psychosis in a year in the Unites States, and about 10,000 die from it. The death rate is higher in the South of the country. Psychosis occurring in people over 50 years old is strongly associated with physical conditions leading to death.

Anonymous Patient Answer

Can psychosis, involutional be cured?

The efficacy of risperidone treatment demonstrated that alleviation and reduction of psychotic symptoms could be achievable in patients with a psychiatric diagnosis of psychosis, involutional.

Anonymous Patient Answer

What are the signs of psychosis, involutional?

Results from a recent clinical trial confirm that the psychotic syndrome of psychosis, involutional is a different entity from that classically recognized as psychotic breakdown.

Anonymous Patient Answer

What is seltorexant?

Recent findings describes for the first time an unexpected phenomenon of increased body weight at baseline compared to controls in patients receiving seltorexant. Recent findings suggest that seltorexant-induced weight gain is unrelated to the inhibition of hunger in the acute phase, but may be due to increased energy expenditure due to an extended suppression of the circadian rhythm. Given this finding and the very short half-life of the drug, dose adjustments of seltorexant in patients with known decreased energy expenditure are unlikely.

Anonymous Patient Answer

Is seltorexant typically used in combination with any other treatments?

On average, seltorexant was co-used with 2.6 other different medications. Combining seltorexant with other agents with different mechanisms of action could theoretically result in undesirable drug interactions and side effects.

Anonymous Patient Answer

Is seltorexant safe for people?

Patients with mental illnesses take at least one medication and, at least in this study, people taking seltorexant for insomnia do not always appear to take multiple medications. There were no adverse events reported in this study with seltorexant; the drug was evaluated and found to have a high safety profile. No evidence of a significant interaction was noted. The lack of an obvious interaction, along with the high rate of discontinuation (12%) and the short duration of the trial in our patient population, indicates that further clinical evidence may be required to determine the safety of seltorexant for patients with such diagnoses.

Anonymous Patient Answer

Have there been other clinical trials involving seltorexant?

Given the potential for serious side effects, these findings do not suggest that physicians (and other scientists) should use seltorexant in their practice. However, the findings may be helpful in limiting clinical trials that could result in the prescription of seltorexant to patients when more safe and effective drugs are available.

Anonymous Patient Answer

How serious can psychosis, involutional be?

Even in the absence of symptoms related to dementia or other cognitive dysfunction, [in older adults it can have significant consequences, including reduced physical and cognitive functioning over time, in addition to being responsible for >30% of admissions to long-term care facilities in Japan] psychosis, involutional in individuals over 75 years of age can be a more serious issue for society.

Anonymous Patient Answer

Has seltorexant proven to be more effective than a placebo?

Recent findings demonstrates that seltorexant is more effective than a placebo in the short-term treatment of sleep onset insomnia. Nevertheless, the long-term effects of such a treatment remain to be determined.

Anonymous Patient Answer
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