EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

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.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 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 for 52 weeks with another antidepressant medicine.

A study to assess the long- term 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, 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 Inadequate response to Antidepressant Therapy

The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.

The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.

The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.

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.

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.

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.

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).

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%.

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.

Arms	Assigned Interventions
Experimental: SSRI/Serotonin/SNRI + TC-5214 1-4 mg Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID	Drug: TC-5214 Tablet, oral, twice daily for 52 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 52 weeks

A study to assess the long- term safety of TC-5214 as an adjunct therapy in patients with major depressive disorder

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSR-D4130C00007.pdf

D4130C00007/Clinical Study Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator