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Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis

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ClinicalTrials.gov Identifier: NCT01001559
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Collaborators:
Red Oak Psychiatry Associates, PA
Baylor Health Care System
Information provided by (Responsible Party):
Pamlab, Inc.

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Retrospective
Condition Major Depressive Disorder
Interventions Drug: L-methylfolate
Drug: Selective serotonin reuptake inhibitor (SSRI)
Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)
Enrollment 242
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Deplin + Antidepressant Antidepressant Alone
Hide Arm/Group Description Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) SSRI or SNRI alone
Period Title: Overall Study
Started 95 147
Completed 95 147
Not Completed 0 0
Arm/Group Title Deplin + Antidepressant Antidepressant Alone Total
Hide Arm/Group Description Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) SSRI or SNRI alone Total of all reporting groups
Overall Number of Baseline Participants 95 147 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 147 participants 242 participants
45.5  (11.9) 41.4  (11.7) 43.0  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 147 participants 242 participants
Female
62
  65.3%
98
  66.7%
160
  66.1%
Male
33
  34.7%
49
  33.3%
82
  33.9%
1.Primary Outcome
Title Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline
Hide Description

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.

Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Deplin + Antidepressant Antidepressant Alone
Hide Arm/Group Description:
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
SSRI or SNRI alone
Overall Number of Participants Analyzed 95 147
Measure Type: Number
Unit of Measure: Participants
17 10
2.Secondary Outcome
Title Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale
Hide Description

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.

Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Deplin + Antidepressant Antidepressant Alone
Hide Arm/Group Description:
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
SSRI or SNRI alone
Overall Number of Participants Analyzed 95 147
Median (Inter-Quartile Range)
Unit of Measure: Days
177
(85 to 299)
231
(126 to 540)
3.Secondary Outcome
Title Number of Hospitalizations Due to MDD
Hide Description Number 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
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deplin + Antidepressant Antidepressant Alone
Hide Arm/Group Description:
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
SSRI or SNRI alone
Overall Number of Participants Analyzed 95 147
Measure Type: Number
Unit of Measure: Hospitalizations due to MDD
1 4
4.Secondary Outcome
Title Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications
Hide Description [Not Specified]
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deplin + Antidepressant Antidepressant Alone
Hide Arm/Group Description:
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
SSRI or SNRI alone
Overall Number of Participants Analyzed 95 147
Measure Type: Number
Unit of Measure: Alterations in antidepressant therapy
135 263
Time Frame AE reporting occurred between January 2007 and September 2009
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Deplin + Antidepressant Antidepressant Alone
Hide Arm/Group Description Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) SSRI or SNRI alone
All-Cause Mortality
Deplin + Antidepressant Antidepressant Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Deplin + Antidepressant Antidepressant Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/93 (1.08%)      3/103 (2.91%)    
General disorders     
Hospitalization * [1]  1/93 (1.08%)  1 3/103 (2.91%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Limited information regarding SAEs is available. Four hospitalizations, among three subjects in the Antidepressant Alone arm, and one hospitalization in the Deplin + Antidepressant arm occurred. No information regarding AE term or SOC is available.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Deplin + Antidepressant Antidepressant Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/93 (60.22%)      68/103 (66.02%)    
Gastrointestinal disorders     
Nausea  9/93 (9.68%)  9 9/103 (8.74%)  9
Constipation  7/93 (7.53%)  7 4/103 (3.88%)  4
Dry Mouth  1/93 (1.08%)  1 2/103 (1.94%)  3
General disorders     
Fatigue  5/93 (5.38%)  5 2/103 (1.94%)  2
Nervous system disorders     
Somnolence  12/93 (12.90%)  12 12/103 (11.65%)  12
Dizziness  3/93 (3.23%)  3 7/103 (6.80%)  7
Psychiatric disorders     
Insomnia  4/93 (4.30%)  4 6/103 (5.83%)  6
Agitation  3/93 (3.23%)  3 6/103 (5.83%)  6
Decreased Appetite  1/93 (1.08%)  1 5/103 (4.85%)  5
Reproductive system and breast disorders     
Sexual Dysfunction  11/93 (11.83%)  11 15/103 (14.56%)  15
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lawrence Ginsberg
Organization: Red Oak Psychiatry Associates
Phone: 281-893-4111 ext 151
EMail: larrydg@earthlink.net
Layout table for additonal information
Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01001559     History of Changes
Other Study ID Numbers: Pamlab D-005
First Submitted: October 22, 2009
First Posted: October 26, 2009
Results First Submitted: April 19, 2013
Results First Posted: December 19, 2013
Last Update Posted: December 19, 2013