Trial Outcomes & Findings for Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis (NCT NCT01001559)
NCT ID: NCT01001559
Last Updated: 2013-12-19
Results Overview
The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline.
COMPLETED
242 participants
60 days
2013-12-19
Participant Flow
Single site, retrospective chart review of subjects administered a combination of Deplin and an SSRI or SNRI. The 242 subjects were 18-70 years of age (inclusive) and received their respective therapies between January 2007 and September 2009.
Criteria that excluded patients were folic acid supplementation \>400mcg, current or a history of psychotic features, bipolar disorder, a history of vagus nerve stimulation, electroconvulsive, or transcranial magnetic stimulation therapy. Any concomitant antipsychotic therapy in the most recent 4 weeks.
Participant milestones
| Measure |
Deplin + Antidepressant
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
|
Antidepressant Alone
SSRI or SNRI alone
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
147
|
|
Overall Study
COMPLETED
|
95
|
147
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
Baseline characteristics by cohort
| Measure |
Deplin + Antidepressant
n=95 Participants
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
|
Antidepressant Alone
n=147 Participants
SSRI or SNRI alone
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 11.9 • n=93 Participants
|
41.4 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
43.0 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
160 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: All participants
The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline.
Outcome measures
| Measure |
Deplin + Antidepressant
n=95 Participants
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
|
Antidepressant Alone
n=147 Participants
SSRI or SNRI alone
|
|---|---|---|
|
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: All participants
The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Median times to peak response. Peak response defined as the first improvement of two or more in the CGI-S from initial visit, and measured the time to the occurrence.
Outcome measures
| Measure |
Deplin + Antidepressant
n=95 Participants
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
|
Antidepressant Alone
n=147 Participants
SSRI or SNRI alone
|
|---|---|---|
|
Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale
|
177 Days
Interval 85.0 to 299.0
|
231 Days
Interval 126.0 to 540.0
|
SECONDARY outcome
Timeframe: 60 daysNumber of hospitalizations due to MDD during treatment were assessed during this retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n-147) from patient charts
Outcome measures
| Measure |
Deplin + Antidepressant
n=95 Participants
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
|
Antidepressant Alone
n=147 Participants
SSRI or SNRI alone
|
|---|---|---|
|
Number of Hospitalizations Due to MDD
|
1 Hospitalizations due to MDD
|
4 Hospitalizations due to MDD
|
SECONDARY outcome
Timeframe: 60 daysOutcome measures
| Measure |
Deplin + Antidepressant
n=95 Participants
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
|
Antidepressant Alone
n=147 Participants
SSRI or SNRI alone
|
|---|---|---|
|
Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications
|
135 Alterations in antidepressant therapy
|
263 Alterations in antidepressant therapy
|
Adverse Events
Deplin + Antidepressant
Antidepressant Alone
Serious adverse events
| Measure |
Deplin + Antidepressant
n=93 participants at risk
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
|
Antidepressant Alone
n=103 participants at risk
SSRI or SNRI alone
|
|---|---|---|
|
General disorders
Hospitalization
|
1.1%
1/93 • Number of events 1 • AE reporting occurred between January 2007 and September 2009
|
2.9%
3/103 • Number of events 3 • AE reporting occurred between January 2007 and September 2009
|
Other adverse events
| Measure |
Deplin + Antidepressant
n=93 participants at risk
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
|
Antidepressant Alone
n=103 participants at risk
SSRI or SNRI alone
|
|---|---|---|
|
Reproductive system and breast disorders
Sexual Dysfunction
|
11.8%
11/93 • Number of events 11 • AE reporting occurred between January 2007 and September 2009
|
14.6%
15/103 • Number of events 15 • AE reporting occurred between January 2007 and September 2009
|
|
Nervous system disorders
Somnolence
|
12.9%
12/93 • Number of events 12 • AE reporting occurred between January 2007 and September 2009
|
11.7%
12/103 • Number of events 12 • AE reporting occurred between January 2007 and September 2009
|
|
Gastrointestinal disorders
Nausea
|
9.7%
9/93 • Number of events 9 • AE reporting occurred between January 2007 and September 2009
|
8.7%
9/103 • Number of events 9 • AE reporting occurred between January 2007 and September 2009
|
|
Nervous system disorders
Dizziness
|
3.2%
3/93 • Number of events 3 • AE reporting occurred between January 2007 and September 2009
|
6.8%
7/103 • Number of events 7 • AE reporting occurred between January 2007 and September 2009
|
|
Psychiatric disorders
Insomnia
|
4.3%
4/93 • Number of events 4 • AE reporting occurred between January 2007 and September 2009
|
5.8%
6/103 • Number of events 6 • AE reporting occurred between January 2007 and September 2009
|
|
Psychiatric disorders
Agitation
|
3.2%
3/93 • Number of events 3 • AE reporting occurred between January 2007 and September 2009
|
5.8%
6/103 • Number of events 6 • AE reporting occurred between January 2007 and September 2009
|
|
Psychiatric disorders
Decreased Appetite
|
1.1%
1/93 • Number of events 1 • AE reporting occurred between January 2007 and September 2009
|
4.9%
5/103 • Number of events 5 • AE reporting occurred between January 2007 and September 2009
|
|
Gastrointestinal disorders
Constipation
|
7.5%
7/93 • Number of events 7 • AE reporting occurred between January 2007 and September 2009
|
3.9%
4/103 • Number of events 4 • AE reporting occurred between January 2007 and September 2009
|
|
General disorders
Fatigue
|
5.4%
5/93 • Number of events 5 • AE reporting occurred between January 2007 and September 2009
|
1.9%
2/103 • Number of events 2 • AE reporting occurred between January 2007 and September 2009
|
|
Gastrointestinal disorders
Dry Mouth
|
1.1%
1/93 • Number of events 1 • AE reporting occurred between January 2007 and September 2009
|
1.9%
2/103 • Number of events 3 • AE reporting occurred between January 2007 and September 2009
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place