CLINICAL TRIAL

Humulin R for Melancholia

Recruiting · 18 - 65 · All Sexes · Toronto, Canada

This study is evaluating whether insulin can improve mood and cognitive function in people with depression.

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About the trial for Melancholia

Eligible Conditions
Mood Disorders · Bipolar Disorder · Major Depressive Disorder (MDD) · Depressive Disorder · Intranasal Insulin · Depressive Disorder, Major · Disease · Anhedonia · Insulin Resistance

Treatment Groups

This trial involves 2 different treatments. Humulin R 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 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Humulin R
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Diluent
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
is mandated by institutional review boards A written and voluntary agreement to take part in a study is required by the institution's review board. show original
Age 18-50
is required for a DSM-5 diagnosis of major depressive disorder show original
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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: 2 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 weeks.
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 Humulin R will improve 1 primary outcome, 12 secondary outcomes, and 9 other outcomes in patients with Melancholia. Measurement will happen over the course of 2 weeks.

Young Mania Rating Scale (YMRS)
2 WEEKS
Scale that assesses manic symptoms. The scale has 11 items and is based on the patient's subjective report of his/her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. Each item assesses a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Typical YMRS baseline scores can vary a lot and they depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2). A higher total score is indicative of worse outcome.
2 WEEKS
Trail Making Test A/B (TMT A/B)
2 WEEKS
Neurocognitive task. Score from the end of each treatment phase.
2 WEEKS
Short Food Frequency Questionnaire (SFFQ)
WEEKS
The SFFQ is a method of collecting the participant's dietary intake on a weekly basis.
WEEKS
Snaith-Hamilton Pleasure Scale (SHAPS)
2 WEEKS
The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14 and higher scores are indicative of greater anhedonia.
2 WEEKS
The DeJong Gierveld Loneliness Scale
2 WEEKS
The DeJong Gierveld Loneliness Scale is a 6-item scale, wherein three statements are made about 'emotional loneliness' and three about 'social loneliness'. There are negatively (items 1-3) and positively (items 4-6) worded items. On the negatively worded items, the neutral and positive answers are scored as "1". Therefore, on questions 1-3 score Yes=1, More or less=1, and No=0. On the positively worded items, the neutral and negative answers are scored as "1". Therefore, on questions 4-6, score Yes=0, More or less=1, and No=1. This gives a possible range of scores from 0 to 6, which can be read as follows: 0= least lonely; 6= most lonely.
2 WEEKS
Addiction Severity Index (ASI)
2 WEEKS
The ASI is a semi-structured interview designed to address seven potential problem areas in substance-abusing patients: medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. A skilled interviewer will gather information on recent (past 30 days) and lifetime problems in all of the problem areas. The ASI provides an overview of problems related to substance, rather than focusing on any single area. The severity ratings are interviewer estimates of the patient's need for additional treatment in each area. The scales range from 0 (no treatment necessary) to 9 (treatment needed to intervene in life-threatening situation). Each rating is based upon the patient's history of problem symptoms, present condition and subjective assessment of his/her treatment needs in a given area.
2 WEEKS
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Who is running the study

Principal Investigator
R. M.
Prof. Rodrigo Mansur, Psychiatrist, Assistant Professor of Psychiatry at the University of Toronto
University Health Network, Toronto

Patient Q & A Section

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

Can melancholia be cured?

Depression and an inability to attain goals can make a person distressed and may impede his or her professional activity. Although these problems can be treated, they cannot be cured.

Anonymous Patient Answer

What are the signs of melancholia?

The melancholic subtype of depression may be best diagnosed when the depressive symptoms are severe, a long history is present, or a strong family history of depression is found. The duration of symptoms is of little clinical usefulness in distinguishing a major depressive episode in the presence of melancholia.

Anonymous Patient Answer

What causes melancholia?

Melancholia and manic episodes can be traced from the biological or cultural standpoint to mood. The underlying mood disorder seems to be genetically inherited, but the specific genes involved are still unknown. The neuro-chemical imbalance hypothesis seems to offer a logical explanation. While it offers more insight into the cause, it raises more questions than answers.

Anonymous Patient Answer

What are common treatments for melancholia?

Treatment is very broad as there are several medications that have not been used, nor evaluated, previously for the purpose of melancholia. The most common treatments for melancholia are antidepressant drugs and an anticonvulsant drug. Many other medications have been used but not investigated in human studies of the disorder.

Anonymous Patient Answer

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

I am afraid that I suffer from depressive episodes. How many other people suffer from it too? answer: This meta-analysis indicates that around 13-25% of the US adult population have depressive or anxiety symptoms. Men are more prone than women for all depressive and anxiety states.

Anonymous Patient Answer

What is melancholia?

Melancholia is defined as a depressive episode marked by prolonged feelings of sadness and fatigue that begin suddenly and persist for 2 weeks or more. It usually begins around the age of 50 and affects about 1 in 25 adults.\n

Anonymous Patient Answer

What is the primary cause of melancholia?

A significant percentage of patients referred for psychiatric interview had no primary depressive disorder. The majority of patients referred for psychiatric interview in this survey showed a variety of factors associated with increased risk for chronic psychopathology. However, only a small percentage were found to have a primary clinical diagnosis of depression, and in this sample the majority lacked features associated with depression (i.e., prolonged depressive episodes and suicidal thoughts/behaviors).

Anonymous Patient Answer

Does melancholia run in families?

Melancholia with and without bipolar features appears to be more common in families than expected from an Mendelian model in general. Whether this is a consequence of genetic heterogeneity or linkage with other psychiatric traits requires further investigation.

Anonymous Patient Answer

How serious can melancholia be?

In an elderly cohort, depressive thoughts are common and have a relatively high level of occurrence compared to depressive thoughts in younger cohorts, and the level of occurrence can vary by the severity of depressive symptoms. Clinicians need to take this finding into account when evaluating patients with non-severe depression.

Anonymous Patient Answer

What does humulin r usually treat?

[The term 'hibernal melancholia' is used for a depressive and anxious disorder similar to a major depression or panic disorder. Patients whose depression responds well to cognitive behavior therapy (such as 'humulin') have a good prognosis.](https://www.ncbi.nlm.nih.

Anonymous Patient Answer

What is the latest research for melancholia?

The findings of this review indicate that clinicians, patients and caregivers need to be aware that there is no treatment that prevents the development of melancholia. Effective preventive strategies are available for people at risk of developing this debilitating mood disorder.

Anonymous Patient Answer

Is humulin r typically used in combination with any other treatments?

In a recent study, findings highlights the importance of optimizing the use and dosing of the therapeutic combination as well as the role of treating any co-existent conditions. A review of the medication guidelines for BPH patients can be observed here.<nowiki>http://www.rsd.com/pdf/medreferral-[bph](https://www.withpower.com/clinical-trials/bph)care.

Anonymous Patient Answer
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