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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID

The purpose of this study is to determine if TC-5214 or placebo (a tablet  that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients with major Depressive Disorder

Research Site

A Multicenter, Randomized,  Double-Blind Parallel Group Placebo-Controlled Phase III,Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

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.

The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.

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.

The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.

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.

The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.

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.

The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.

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.

The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.

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.

A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17
consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17
individual symptom scores; the total score can range from 0 to 52.  Higher HAMD-17 scores indicate more severe depression.

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.

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.  CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.

A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale, the total score can range from 0 to 56. Higher HAM-A scores indicate higher levels of anxiety.

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).

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease.  Higher scores indicate more severe impairment.  The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease.  Higher scores indicate more severe impairment.  The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease.  Higher scores indicate more severe impairment.  The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.

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%.

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life.  The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life.  The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.

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 (minimum -0.415) 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.

A self-administered scale to be used by clinical subjects to rate suffering over
the past week with regard to irritability symptoms. The total SIS score is the
sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11-
point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly,
and 10=extremely. The SIS also records the number of days impaired by
irritability.

Arms	Assigned Interventions
Experimental: SSRI/Serotonin/SNRI+ TC-5214 0.5 mg Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID	Drug: TC-5214 Tablet, oral, twice daily for 8 weeks
Experimental: SSRI/Serotonin/SNRI + TC-5214 2 mg Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID	Drug: TC-5214 Tablet, oral, twice daily for 8 weeks
Experimental: SSRI/Serotonin/SNRI + TC-5214 4 mg Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID	Drug: TC-5214 Tablet, oral, twice daily for 8 weeks
Placebo Comparator: SSRI/Serotonin/SNRI + Placebo Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID	Drug: Placebo Tablet, oral, twice daily for 8 weeks

A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients with major Depressive Disorder

Official Title

Medical condition

Phase

Healthy volunteers

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Documents available

CSR-D4130C00004.pdf

D4130C00004/Clinical Study Protocol

Trial Results Summaries

Contacts

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Principal Investigator