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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.