Trial · NCT01001559

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

NCT01001559, Completed, Pamlab, Inc.; results first posted 2013-12-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis. Trials, record NCT01001559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01001559

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
NCT number: NCT01001559
Status: Completed
Enrollment: 242 participants, actual
Lead sponsor: Pamlab, Inc.
Conditions: Major Depressive Disorder
Interventions: L-methylfolate, Selective serotonin reuptake inhibitor (SSRI), Serotonin and norepinephrine reuptake inhibitor (SNRI)
First posted: 2009-10-26
Last updated: 2013-12-19
Results first posted: 2013-12-19

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline	60 days	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.
Secondary	Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale	60 days	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.
Secondary	Number of Hospitalizations Due to MDD	60 days	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
Secondary	Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications	60 days

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline	60 days	All participants	Participants	NUMBER
SECONDARY	Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale	60 days	All participants	Days	MEDIAN
SECONDARY	Number of Hospitalizations Due to MDD	60 days		Hospitalizations due to MDD	NUMBER
SECONDARY	Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications	60 days		Alterations in antidepressant therapy	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline	Deplin + Antidepressant	17		Participants
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline	Antidepressant Alone	10		Participants
Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale	Deplin + Antidepressant	177	Inter-Quartile Range 85 to 299	Days
Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale	Antidepressant Alone	231	Inter-Quartile Range 126 to 540	Days
Number of Hospitalizations Due to MDD	Deplin + Antidepressant	1		Hospitalizations due to MDD
Number of Hospitalizations Due to MDD	Antidepressant Alone	4		Hospitalizations due to MDD
Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications	Deplin + Antidepressant	135		Alterations in antidepressant therapy
Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications	Antidepressant Alone	263		Alterations in antidepressant therapy

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Deplin + Antidepressant	95
Overall Study	STARTED	Antidepressant Alone	147
Overall Study	COMPLETED	Deplin + Antidepressant	95
Overall Study	COMPLETED	Antidepressant Alone	147
Overall Study	NOT COMPLETED	Deplin + Antidepressant	0
Overall Study	NOT COMPLETED	Antidepressant Alone	0

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Sexual Dysfunction	Reproductive system and breast disorders	Deplin + Antidepressant	11	93	11
other	Sexual Dysfunction	Reproductive system and breast disorders	Antidepressant Alone	15	103	15
other	Somnolence	Nervous system disorders	Deplin + Antidepressant	12	93	12
other	Somnolence	Nervous system disorders	Antidepressant Alone	12	103	12
other	Nausea	Gastrointestinal disorders	Deplin + Antidepressant	9	93	9
other	Nausea	Gastrointestinal disorders	Antidepressant Alone	9	103	9
other	Dizziness	Nervous system disorders	Deplin + Antidepressant	3	93	3
other	Dizziness	Nervous system disorders	Antidepressant Alone	7	103	7
other	Insomnia	Psychiatric disorders	Deplin + Antidepressant	4	93	4
other	Insomnia	Psychiatric disorders	Antidepressant Alone	6	103	6

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Deplin + Antidepressant
Total, all-cause mortality	Antidepressant Alone
Total, other adverse events	Deplin + Antidepressant	56	93
Total, other adverse events	Antidepressant Alone	68	103
Total, serious adverse events	Deplin + Antidepressant	1	93
Total, serious adverse events	Antidepressant Alone	3	103

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21311704	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Deplin + Antidepressant vs Antidepressant Alone: Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline	Trial comparisons
Deplin + Antidepressant vs Antidepressant Alone: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01001559

GET https://conductscience.org/api/trials/v1/NCT01001559/events?page=2

API reference For AI assistants