mecamylamine has been researched along with Fatigue in 1 studies
Mecamylamine: A nicotinic antagonist that is well absorbed from the gastrointestinal tract and crosses the blood-brain barrier. Mecamylamine has been used as a ganglionic blocker in treating hypertension, but, like most ganglionic blockers, is more often used now as a research tool.
Fatigue: The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.
Excerpt | Relevance | Reference |
---|---|---|
" Safety and tolerability were assessed by monitoring adverse events, vital signs, and physical and laboratory parameters." | 2.80 | Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study. ( Desai, D; Dunbar, G; Eriksson, H; Hosford, D; Szamosi, J; Tummala, R; Wilson, E, 2015) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 1 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Tummala, R | 1 |
Desai, D | 1 |
Szamosi, J | 1 |
Wilson, E | 1 |
Hosford, D | 1 |
Dunbar, G | 1 |
Eriksson, H | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadeq[NCT01152554] | Phase 3 | 813 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired). (NCT01152554)
Timeframe: Randomization (Week 0) to end of treatment (Week 52)
Intervention | units on a scale (Mean) |
---|---|
TC-5214 | -6.98 |
Placebo | -7.44 |
The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%. (NCT01152554)
Timeframe: Randomization (Week 0) to end of treatment (Week 52)
Intervention | units on a scale (Mean) |
---|---|
TC-5214 | 10.83 |
Placebo | 11.62 |
A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity. (NCT01152554)
Timeframe: Randomization (Week 0) to end of treatment (Week 52)
Intervention | units on a scale (Mean) |
---|---|
TC-5214 | -1.8 |
Placebo | -1.6 |
The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated. (NCT01152554)
Timeframe: Randomization (Week 0) to end of the follow-up period (Week 54)
Intervention | percentage of participants analyzed (Number) |
---|---|
TC-5214 | 10.5 |
Placebo | 7.0 |
The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated. (NCT01152554)
Timeframe: Randomization (Week 0) to end of the follow-up period (Week 54)
Intervention | percentage of participants analyzed (Number) |
---|---|
TC-5214 | 82.4 |
Placebo | 84.6 |
The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated. (NCT01152554)
Timeframe: Randomization (Week 0) to end of the follow-up period (Week 54)
Intervention | percentage of participants analyzed (Number) |
---|---|
TC-5214 | 3.6 |
Placebo | 2.5 |
"The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01152554)
Timeframe: Week 12 to Week 24
Intervention | percentage of participants analyzed (Number) |
---|---|
TC-5214 | 18.2 |
Placebo | 20.6 |
"The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms." (NCT01152554)
Timeframe: Week 12 to Week 52
Intervention | percentage of patients analyzed (Number) |
---|---|
TC-5214 | 9.7 |
Placebo | 12.5 |
A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state. (NCT01152554)
Timeframe: Randomization (Week 0) to end of treatment (Week 52)
Intervention | units on a scale (Mean) | |
---|---|---|
EQ-5D index score | EQ-5D VAS score | |
Placebo | 0.071 | 11.9 |
TC-5214 | 0.081 | 8.7 |
1 trial available for mecamylamine and Fatigue
Article | Year |
---|---|
Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study.
Topics: Adult; Antidepressive Agents; Constipation; Depressive Disorder, Major; Dizziness; Double-Blind Meth | 2015 |