Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)

An observational study of Major Depressive Disorder, run by Pamlab, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will be an observational study in which patients who have been prescribed Deplin® are invited to participate in surveys regarding their experiences with Deplin®. The purpose of this study is to increase the understanding of the role of L-methylfolate among patients who are candidates for Deplin®, provide… Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: Deplin®
Type of treatment: Pill or oral medicine
How many people: 554 participants
Where: 2 sitesUnited States
Study dates: Nov 2010to Apr 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Patients with Depression Who Have Been Prescribed Deplin®

Who may be able to join

New Deplin® Start
Only for patients with depression who have been prescribed brand name Deplin® to help metabolic management of depression.
Clinically depressed patients who have been prescribed Deplin® in combination with an antidepressant.
At the start of antidepressant therapy
As augmentation to antidepressant therapy

Who cannot join

Patients who do not meet DSM IV criteria for major depression
If participant indicates that he or she did not get a prescription for Deplin®, he/she will not be able to complete the survey(s).
For follow-up surveys, if the participant indicates that he/she has not been taking Deplin®, he/she will not be able to complete the survey(s).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Moses Cone Family Practice Center
Greensboro, North Carolina, 27401
Vanderbilt University School of Medicine
Nashville, Tennessee, 37212

Other trials in United States

About this study

Read the detailed description

Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Deplin® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their Deplin® prescription, and then a follow-up survey after 90 days of treatment with Deplin®. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Deplin® as directed. Patients will also receive educational materials about managing their depression.

Conditions: Major Depressive Disorder
Being tested: Deplin®
Keywords: L-methylfolate, Deplin, depression, antidepressant, combination therapy, augmentation, folate, folic acid, homocysteine, methionine, MTHFR genotype, C677T mutation, vitamin B6, vitamin B12
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deplin®Other
Deplin® is an orally administered medical food available in a 7.5mg tablet or a 15mg caplet with each containing either 7.5mg or 15mg of L-methylfolate, respectively - which is the primary biologically active and immediately bioavailable form of folate. Dosage for this study will be 1 15mg caplet QD.

Study groups in NCT01369030
Study group	Role	What they receive
Deplin®		Subjects with depression who have been prescribed Deplin® daily. Receives: Other: Deplin®

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value "0" represents not at all, "1" several days, "2" indicates more than half the days, and the maximum value "3" stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
Measured: Baseline to Endpoint (90 days)

Secondary outcomes (2)

Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms
Measured: Baseline to Endpoint (90 days)
Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale
Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating "not at all satisfied" and 9 as "very satisfied."
Measured: Baseline to Endpoint (90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Apr 2012

First posted8 Jun 2011 (estimated)
Study startNov 2010
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 554 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01369030
Sponsor's protocol ID: D-009
Status last verified: May 2014
First submitted: 17 May 2011
Last updated: 3 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
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Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
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Not yet recruiting
Sedation and Guided Education for Depression Study
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RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults
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Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
ClinicalTrials.gov ID: NCT01369030
Acronym / sponsor ID: D-009
Conditions: Major Depressive Disorder
Keywords: L-methylfolate, Deplin, depression, antidepressant, combination therapy, augmentation, folate, folic acid
Study type: Observational
Recruitment status: Completed
Enrolment: 554 participants (actual)
Lead sponsor: Pamlab, Inc.Industry (pharma, biotech, devices)
Collaborators: InfoMedics, Inc.
Study start: Nov 2010
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 8 Jun 2011 (estimated)
Results: Posted 3 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Deplin®	–	Other: Deplin®Subjects with depression who have been prescribed Deplin® daily.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients with Depression Who Have Been Prescribed Deplin®

Key inclusion criteria (5 listed)

New Deplin® Start
Only for patients with depression who have been prescribed brand name Deplin® to help metabolic management of depression.
Clinically depressed patients who have been prescribed Deplin® in combination with an antidepressant.
At the start of antidepressant therapy
As augmentation to antidepressant therapy

Key exclusion criteria (3 listed)

Patients who do not meet DSM IV criteria for major depression
If participant indicates that he or she did not get a prescription for Deplin®, he/she will not be able to complete the survey(s).
For follow-up surveys, if the participant indicates that he/she has not been taking Deplin®, he/she will not be able to complete the survey(s).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Deplin®Deplin® is an orally administered medical food available in a 7.5mg tablet or a 15mg caplet with each containing either 7.5mg or 15mg of L-methylfolate, respectively - which is the primary biologically active and immediately bioavailable form of folate. Dosage for this study will be 1 15mg caplet QD.	Other	Deplin®

Primary outcome

Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to Endpoint (90 days)
The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value "0" represents not at all, "1" several days, "2" indicates more than half the days, and the maximum value "3" stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.

2 secondary outcomes

Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms
Time frame: Baseline to Endpoint (90 days)
Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale
Time frame: Baseline to Endpoint (90 days)

Results and safety

Results posted to the registry on 3 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deplin®	594	554

Primary outcome: Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)

Time frame: Baseline to Endpoint (90 days). Mean (Standard Deviation). Unit: units on a scale

Measure	Deplin® n = 554
Mean baseline PHQ-9 Score	14.6 (5.8)
Mean endpoint PHQ-9 Score	6.1 (5.0)
Mean reduction in PHQ-9 Score	8.5 (6.3)

Deplin®: Mean Difference (Net): 8.5, p = 0.000, Wilcoxon signed-rank test

Population analysed: Analyses were performed on the 554 patients who had a baseline PHQ-9\>=5 and further analyzed by baseline depression severity groups defined by baseline PHQ-9 scores: 5\<=PHQ-9\<=9; 10\<=PHQ-9\<=14; 15\<=PHQ-9\<=19; and 20\<=PHQ-9\<=27.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deplin®	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Patients self-enrolled in the program and data presented was based on self-reported close-ended questions; selection bias may be present for those who chose not to enroll or complete the surveys. No clinical evaluations were conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
Not yet recruiting
Sedation and Guided Education for Depression Study
Major Depressive Disorder (MDD)
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults
Recruiting
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard C Shelton, M.D. principal investigator

Vanderbilt University School of Medicine

Sloan Manning, M.D. principal investigator

Mood Disorders Clinic at Moses Cone Family Practice Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder, run by Pamlab, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) (time frame: Baseline to Endpoint (90 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01369030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014; AzTrials last refreshed its copy on 28 Oct 2026.