Treatment for Depressive Disorder, Treatment-Resistant

Phase-Based Estimates
1
Effectiveness
2
Safety
Cumming School of Medicine, University of Calgary, Calgary, Canada
Depressive Disorder, Treatment-Resistant+4 More
Eligibility
18+
All Sexes
Eligible conditions
Depressive Disorder, Treatment-Resistant

Study Summary

This study is evaluating whether fecal transplantation might be an effective treatment for depression.

See full description

Eligible Conditions

  • Depressive Disorder, Treatment-Resistant
  • Psychosis, Involutional
  • Depression
  • Melancholia
  • Depressive Disorder, Major
  • Depressive Disorder
  • Major depressive disorder, recurrent episode

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 2 secondary outcomes, and 5 other outcomes in patients with Depressive Disorder, Treatment-Resistant. Measurement will happen over the course of from baseline (pre-intervention) to the final visit (week 13).

Week 13
Change in the MADRS total score
GI tolerability of patients with Irritable Bowel Syndrome (IBS)
Side effects as reported on the Toronto Side Effect Scale (TSES)
To assess the effect of FMT on microbiome profile
To examine imaging changes
changes in inflammatory markers (Blood)
changes in inflammatory markers (stool)
changes in serum cytokines

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo oral Capsules
Placebo group

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 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 2 & 3 and have had some early promising results.

Placebo oral Capsules
Biological
Placebo casules are inactive capsules that look and weigh the same as the Active FMT caspules. Participants will follow the same schedule as the Active arm.
FMT capsules
Biological
Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool and each containing 0.67 ml of pelleted intestinal microbes. PArticipants will recieve a loading dose of 60 capsules over 3 consecutive days followed by a booster dose of 20 caspules 1 month after and a second similar booster dose a month after that

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (pre-intervention) to the final visit (week 13)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline (pre-intervention) to the final visit (week 13) for reporting.

Who is running the study

Principal Investigator
V. T.
Valerie Taylor, Head of Psychiatry
University of Calgary

Closest Location

Cumming School of Medicine, University of Calgary - Calgary, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47
Medical history suggestive of Treatment Resistant Depression (TRD). (inadequate response to at least 2 approved antidepressants. at least one of which is in the current episode of depression)48
Have been on a current treatment with a approved antidepressant at an adequate dose for at least 8 weeks
A MADRS score of ≥ 19 at screening and visit 2
- Participants who will be included in the IBS-D cohort should have a confirmed diagnosis of IBS-D as indicated by the referring gastroenterologist.
Participants should be at least 18 years old and not older than 65 years at the day of screening

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 are the signs of depressive disorder, treatment-resistant?

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Signs of depression include a prolonged period of sadness, recurrent thoughts of death, and a lack of interest in past hobbies, as well as low self-esteem, fatigue or hopelessness with regard to everyday tasks. Lack of interest, lethargy, and lack of engagement in daily routines are the main criteria used to diagnose depression in the DSM-IV. The current article also examines the symptoms of depression found in the DSM-IV. What are the signs of treatment-resistant depression? This article examines and compares the signs of depression detected in the DSM-IV and the symptoms of treatment-resistant depression.

Unverified Answer

What are common treatments for depressive disorder, treatment-resistant?

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It is important to notice the differences in treatment according to the severity of the depressive disorder even after three inpatient treatments. Patients with depressive disorders that are treatment-resistant or persistently depressed need the addition of electroconvulsive therapy and/or the combination antidepressant with atypical antipsychotics to get remission.

Unverified Answer

What causes depressive disorder, treatment-resistant?

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In this population of non-psychiatric inpatients in England, the strongest factor influencing depressive disorder, treatment-resistance and self-harm was recent social adversity. Psychological distress is a significant factor in self-harm, suggesting that more effective social support may help prevent self-harm in this high-risk group. Findings highlight the need for additional prospective studies in primary care settings to identify risk factors for depression and self-harm and for depression to be assessed in patients with self-harm.

Unverified Answer

Can depressive disorder, treatment-resistant be cured?

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Although several studies have proposed that certain subgroups of depression such as treatment-resistant MDD are likely to have poorer outcomes, there is no evidence that treatment-resistant MDD is either more difficult to taper off an antidepressant medication or more difficult to be cured by an extended course of treatment.

Unverified Answer

How many people get depressive disorder, treatment-resistant a year in the United States?

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Approximately 10% of persons with a long term history of major depression received antidepressant treatment the last year. On average 6.3 months was spent receiving treatment and 8.8 for every 100 persons. A longer duration of untreated depression predicted a longer duration of actual treatment.

Unverified Answer

What is depressive disorder, treatment-resistant?

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Approximately 1 in 5 adults will suffer from untreated major depressive disorder at some time over their life. Among individuals with MDD, approximately 30% will develop a treatment resistant mood disorder (resistance to antidepressant treatment) and more than one-third will meet criteria for borderline personality disorder. A significant number of patients with a treatment-resistant mood disorder will have other co-occurring illnesses that worsen their illness outcomes, including smoking and substance abuse.

Unverified Answer

Does treatment improve quality of life for those with depressive disorder, treatment-resistant?

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As it is unlikely that treatment is effective for people at the end of the course of treatment, people with treatment-resistant depression may benefit when they remain on antidepressant treatment even when the antidepressant treatment has not responded, even if the new medication does not show superiority over previous agents.

Unverified Answer

Is treatment typically used in combination with any other treatments?

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Currently, a limited number of therapies are being recommended by physicians and their treatments are being prescribed in combination with other treatments. The type of treatment used is not often specified in the prescribing information. It is important for patients to be aware of the additional treatments and their possible combinations, to take responsibility for the course of the illness, and for them to communicate with physicians about their treatment and expectations to help each other as a team.

Unverified Answer

Have there been any new discoveries for treating depressive disorder, treatment-resistant?

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There have been no new studies of sufficient methodology to be applicable to our patients. Our patients were not adequately enrolled into a study, and studies were often terminated rather than continuing. There were no randomized controlled trials or prospective studies to determine the efficacy of a novel treatment, and there were very few controlled trials of antidepressants in treatment-resistant depression. We believe that a more rigorous trial of atypical antipsychotic medication in treatment-resistant depression is warranted.

Unverified Answer

What are the latest developments in treatment for therapeutic use?

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Current research on depression, mood disorders, and treatment resistant depression offers the use of new medications, including selective serotonin reuptake inhibitors (SSRIs) and monoamine oxidase inhibitors (MAOIs) as treatment options. There are two medications known as selective serotonin reuptake inhibitors (SSRIs), anserin and milnacipran, and one medication known as monoamine oxidase inhibitors (MAOIs), moclobemide, which can improve treatments, however neither therapy is sufficient alone. The treatments of depression usually must be administered for a prolonged period of time as long as it takes to show efficacy.

Unverified Answer

Has treatment proven to be more effective than a placebo?

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There is currently no good evidence that treatment for depression is more effective than a placebo or of any benefit for a short period of time. This is a review of the available evidence, mostly on a small number of patients.

Unverified Answer

What are the common side effects of treatment?

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Many patients reported common side effects including headache, rash, fatigue and sweating. They were often transient and did not require treatment. As most patients were satisfied with their initial treatment the side effect profile of a new antidepressant was not as important as treatment type (monotherapy/switch) and type of first-line SSRI (escitalopram or sertraline).

Unverified Answer
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