Treatment for Psychosis, Involutional

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
McMaster University, Hamilton, Canada
Psychosis, Involutional+3 More
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a biomarker algorithm can predict treatment outcome for patients with a major depressive episode.

See full description

Eligible Conditions

  • Psychosis, Involutional
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 3 secondary outcomes, and 2 other outcomes in patients with Psychosis, Involutional. Measurement will happen over the course of Baseline to Week 8.

Baseline to Week 8
Change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline
Clinical response
Time to clinical response
Week 12
Week 12 clinical outcome - Response
Week 12
Week 12 clinical outcome - Remission
Week 8
Remission at Week 8

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

4 Treatment Groups

Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole
1 of 4
Random Allocation; Escitalopram + Brexpiprazole
1 of 4
Random Allocation; Placebo
1 of 4
Allocation by Predictive Biomarker Algorithm; Placebo
1 of 4
Active Control
Non-Treatment Group

This trial requires 400 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment 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 4 and have been shown to be safe and effective in humans.

Allocation by Predictive Biomarker Algorithm; Escitalopram + BrexpiprazolePatients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted as non-responders to escitalopram monotherapy will receive open-label escitalopram (10-20 mg/d) and blinded brexpiprazole (0.5-2 mg/d) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.
Random Allocation; Escitalopram + BrexpiprazolePatients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg/d) and blinded brexpiprazole (0.5-2 mg/d) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.
Random Allocation; Placebo
Drug
Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg/d) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.
Allocation by Predictive Biomarker Algorithm; Placebo
Drug
Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted to respond to escitalopram monotherapy will receive open-label escitalopram (10-20 mg/d) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 8 and week 8 to week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 8 and week 8 to week 12 for reporting.

Who is running the study

Principal Investigator
S. K.
Prof. Sidney Kennedy, Professor of Psychiatry, University of Toronto, Arthur Sommer Rotenberg Chair in Suicide & Depression Studies, St. Michael's Hospital, Principal Investigator, Canadian Biomarker Integration Network for Depression, University Health Network
University Health Network, Toronto

Closest Location

McMaster University - Hamilton, Canada

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients who are 18 to 60 years old and are not hospitalized. show original
The text states that the person meets the DSM-5 criteria for MDE in MDD as determined by the MINI. show original
The episode must last for at least three months. show original
Free of any psychotropic medications for a week before their first visit. show original
The individual has a MADRS score of at least 24. show original
Patients
The ability to fluently speak English so they can complete the interviews and self-report questionnaires. show original

Patient Q&A Section

How many people get melancholia a year in the United States?

"This estimate is based on epidemiologic studies that have been done in the past and does not include all the people who might have this diagnosis. At least half of all people with MD/DS will have at least one of the DSM-IV depressive episodes at some point in their life." - Anonymous Online Contributor

Unverified Answer

What are common treatments for melancholia?

"Melancholia may have different aspects depending on the patient, as they may have either depression or anxiety as a key symptom, or both. Treating only the anxiety is no long enough to manage the symptom and the depression. Instead, if the person are diagnosed with a depressive aspect, the treatment typically consists of mood stabilization, psychotherapy, or both. A treatment plan using different modalities, combined with treatment of the anxiety may be successful for most patients. This is a common issue in clinical practice since it makes the treatment of patients with mood disorders difficult." - Anonymous Online Contributor

Unverified Answer

What causes melancholia?

"Melancholia is a common psychotic illness in a significant portion of people and its cause remains elusive. Patients need access to a balanced medical-psychiatric approach, along with an understanding of their psychiatric history and treatment options, that allows them to formulate individual treatment plans." - Anonymous Online Contributor

Unverified Answer

Can melancholia be cured?

"Mood stabilizers seem to be a promising tool to treat melancholia. However, additional studies are needed before we can conclude that this is a bona fide means to treat this chronic medical condition." - Anonymous Online Contributor

Unverified Answer

What are the signs of melancholia?

"Patients may experience depressed mood and anhedonia and show suicidal tendencies of melancholic features. In addition, there were also some similarities of depressive symptoms without melancholic features found to be similar to those with melancholic features. The difference between melancholic features and depressive symptoms may be the reason for the difficulty of discriminating between them from clinical perspective." - Anonymous Online Contributor

Unverified Answer

What is melancholia?

"Melancholy is a disorder characterized by pervasive depression. For most people, the onset is gradual, and the symptoms tend to fluctuate and ebb over time. A person suffering from melancholy is typically reluctant to change his or her habits because they are so ingrained. This makes recovery from melancholia more difficult. Melancholic depression presents with major depressive episodes (including postpartum depression) more frequently, and may also be associated with more severe depression and anxiety. Melancholeic depression should not be overlooked in diagnosing and treating major depressive disorder." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with melancholia?

"Data from a recent study of this study suggest that improvements in QOL are possible following treatment for MDD, with patients experiencing reductions over the 6- to 12-week follow-up period. Further research into the specific effects of treatment is required to further advance research on treatments for MDD." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"The present study demonstrated the common side effects of treatment and showed that the side effect burden of patients with depression was high. More extensive evaluation of medical side effects for patients with depression is needed to determine their full potential." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for melancholia?

"Patients with melancholic features have an increased likelihood of being older. No significant gender or ethnicity differences were detected. An increased likelihood of psychiatric morbidity was found, specifically for anxiety and depression, but not for somatizations or sleep disturbances." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"Results from a recent paper provides significant insight into what patients think is the most difficult part--medical treatment of the disorder. There is often an underdiagnosis of depression or other mood illness (as suggested by these data) and a more-severe appraisal of the mental health needs. Thus, if the primary care physician can help in educating patients and addressing their needs, many patients report that care for their condition is good. They believe most people with primary biliary cirrhosis are better off if they continue to have an active attitude toward treatment. Thus, a proactive approach and a positive attitude to self-care are especially important for patients with chronic conditions; they are the cornerstone of any success." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of melancholia?

"In many cases with melancholia, the depressive states and/or symptoms are not caused by the primary brain lesion. Rather, they are caused by the secondary psychological effect of a primary brain lesion, such a loss of the limbic structure, or lesion of the brainstem (see 'Pathophysiology' section below)." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets melancholia?

"The average age of onset of depressive episodes (mean age = 38.6) was younger than the previously published population-based estimates for melancholia. Older patients with severe depression have more severe symptoms, and higher level of psychopathology at onset of diagnosis. Therefore, older patients require a more intensive and intensive psychosocial treatment in which they can be included." - Anonymous Online Contributor

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