TS-161 (50 - 100 mg) for Depressive Disorder, Treatment-Resistant

1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Depressive Disorder, Treatment-Resistant+5 More
TS-161 (50 - 100 mg) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Depressive Disorder, Treatment-Resistant

Study Summary

Antidepressant Effects of TS-161 in Treatment-Resistant Depression

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Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether TS-161 (50 - 100 mg) will improve 1 primary outcome and 15 secondary outcomes in patients with Depressive Disorder, Treatment-Resistant. Measurement will happen over the course of Baseline, Day 21.

At specific timepoints within each treatment condition indicated in the protocol.
Incidence of AEs and total scores using the Clinician Administered Dissociative States Scale (CADSS), Young Mania Rating Scale (YMRS), the Brief Psychiatric Rating Scale (BPRS), vital signs, changes in clinical laboratory evaluations, and ECGs.
Day 21
Gamma power measured via MEG
Day 1
Change from baseline on item 10 (suicidality) of the MADRS and total score on the C-SSRS, and the Scale for Suicidal Ideation (SSI)
Change from baseline on the HDRS, HAM-A, the PANAS, Snaith Hamilton Pleasure Scale (SHAPS), and the Temporal Experience of Pleasure Scale (TEPS) scales
Proportion of participants achieving response (defined as a >=50% reduction from baseline in MADRS total score)
Proportion of participants in remission (defined as MADRS total score <=10)
Day 1
Change from baseline on item 10 (suicidality) of the MADRS and total score on the C-SSRS, and the Scale for Suicidal Ideation (SSI).
Change from baseline on the HDRS, HAM-A, the PANAS, Snaith Hamilton Pleasure Scale (SHAPS), and the Temporal Experience of Pleasure Scale (TEPS) scales.
Proportion of participants achieving response (defined as a >/=50% reduction from baseline in MADRS total score).
Proportion of participants in remission (defined as MADRS total score =10)
Day 1
Change from baseline on MADRS total scores
Day 21
Changes in activity in the frontolimbic circuitry
Day 20
[1H]-MRS correlates with changes in MADRS score
Day 21
[1]H-MRS correlates with changes in MADRS score
Baseline, Day 21
Change from baseline on Montgomery-Asberg Depression Rating Scale (MADRS) total scores
Measures and evaluations assess various aspects of clinical condition, adverse events, and mood and anxiety symptomology
Incidence of AEs and total scores using the Clinician Administered Dissociative States Scale (CADSS), Young Mania Rating Scale (YMRS), the Brief Psychiatric Rating Scale (BPRS), vital signs, changes in clinical laboratory evaluations, and ECGs

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

No Control Group
2
Placebo group

This trial requires 25 total participants across 2 different treatment groups

This trial involves 2 different treatments. TS-161 (50 - 100 Mg) is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

2Individuals in Arm 2 will receive daily double-blinded placebo for three weeks during Test Session 1 and daily double-blinded TS-161 for three weeks during Test Session 2.
1Individuals in Arm 1 will receive daily double-blinded TS-161 for three weeks during Test Session 1 and daily double-blinded placebo for three weeks during Test Session 2.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 230 min post-drug, and days 1, 2, 3, 7, 14, and 20, per test session
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 230 min post-drug, and days 1, 2, 3, 7, 14, and 20, per test session for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Are able to understand the study and can provide your own consent.
Are aged 18 to 65.
Are willing to undergo all study procedures and are available for the duration of the study.
Have major depressive disorder.
Have a current episode of depression lasting at least 4 weeks.
Ability to take oral medication.
Have not responded to at least one antidepressant.
For females of reproductive potential: use of contraception while in the study and for an additional 4 weeks after stopping the study drug.
For males of reproductive potential: use of condoms or other types of birth control with partner while in the study and for an additional 3 months after stopping the study drug.
Agree to be hospitalized at the NIH Clinical Center.

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 common treatments for depressive disorder, treatment-resistant?

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This article discusses the many common treatments that patients with MDD, TDRD, or both experience to manage their symptoms of depression. Clinicians should be aware of the side effects of most commonly prescribed medications as they may adversely affect patient safety, quality of life, and satisfaction. Clinicians should be vigilant and ensure patients receive optimal treatment recommendations given the high costs and adverse effects associated with these medications. In addition, patients with MDD should not be withheld treatment with antidepressants based on side effects, because many side effects resolve once a patient is treated with antidepressant medications. Rather, side effects should first be determined if the patient is likely to respond to treatment and then if side effects persist after the first antidepressant.

Unverified Answer

Can depressive disorder, treatment-resistant be cured?

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Depressive disorder, treatment-resistant, is characterized by high rates of depressive symptoms of all intensity and can hardly be cured. Hence, depressive disorder, treatment-resistant, cannot be cured, and there is no need for a 'cure' label which is not the case for other mental illnesses.

Unverified Answer

What are the signs of depressive disorder, treatment-resistant?

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The prevalence of treatment-resistant depression in this Australian study with a relatively high rate of treatment non-compliance (63.4%) is surprising. It is imperative to identify and treat non-compliant patients with a view to improving treatment outcomes.

Unverified Answer

What causes depressive disorder, treatment-resistant?

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The cause of treatment-resistant depression remains unknown. However, stressful life events in early life or premenstrual dysphoric disorder are linked with depression and bipolar I patients. Anxiety or depression are also a common comorbidity of schizophrenia, and have genetic links, particularly those involving serotonin transporter gene polymorphisms.

Unverified Answer

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

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This is the first study to present national estimates in the United States of the number of patients with treatment-resistant depression. There was no evidence of a gender difference. Results from a recent clinical trial suggest that depressive disorders are common.

Unverified Answer

What is depressive disorder, treatment-resistant?

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There is no one clinical definition or DSM criterion for treatment-resistant depression. There are different kinds of clinical definitions and diagnoses made by different experts, none of whom have consensus agreement. There are also different categories of treatment response, some of which are based on symptom severity and some on the patient's treatment history.

Unverified Answer

Does ts-161 (50 - 100 mg) improve quality of life for those with depressive disorder, treatment-resistant?

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Ts-161 had only modest antidepressant effects in a group of patients who were all treatment-refractory. Ts-161 did not improve QOL or cognition in the entire study sample.

Unverified Answer

Has ts-161 (50 - 100 mg) proven to be more effective than a placebo?

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Ts-161 (50 - 100 mg) was effective in alleviating depression symptoms such as fatigue, anxiety, and insomnia in treatment-resistant depressed patients, providing proof for the first time of the effect of Ts-161 in the treatment-resistant patients.

Unverified Answer

What is the latest research for depressive disorder, treatment-resistant?

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There is little and inconsistent evidence supporting the use of alternative therapies for the treatment of treatment-resistant depression. The evidence regarding the effectiveness and safety of such treatments are limited and therefore more investigations are required. The number of trials evaluating alternative therapies is increasing.

Unverified Answer

Is ts-161 (50 - 100 mg) safe for people?

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The safety and effect profile of ts-161 in this pilot study were consistent with a clinical trial in ADHD. Findings from a recent study suggest that 50 to 100 mg of ts-161 is a safe, well tolerated dose for use in a larger clinical trial population.

Unverified Answer

Who should consider clinical trials for depressive disorder, treatment-resistant?

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Clinical trials may be appropriate for depressed patients treatment-resistant to treatment at this time (2013). Those with prior depression may be more likely to get more benefit from treatment. However, this study had a low number of treatments experienced and low remission rates. Additional trials are needed.

Unverified Answer

Is ts-161 (50 - 100 mg) typically used in combination with any other treatments?

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Ts-161, 50-100 mg/day, is more effective and well-tolerated when taken in combination with another drug; however, many combinations of 2 or more therapeutically potent TCAs are sometimes used in the clinic for some conditions, including depression.

Unverified Answer
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