Major Depressive DisorderNCT01001559
Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
An observational study of Major Depressive Disorder, run by Pamlab, Inc. at 1 site in United States.
Trial summary
This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- L-methylfolate, Selective serotonin reuptake inhibitor (SSRI) and Serotonin and norepinephrine reuptake inhibitor (SNRI)
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2011
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults ages 18-70 experiencing an episode of major depression
Who may be able to join
- Males or females age 18-70
- The active arm (Arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a CGI-S of ≥4 who began Deplin and SSRI or SNRI therapy at the same time beginning in January 2007 to the present; and, Control group (Arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began SSRI or SNRI therapy matched in severity (CGI-S of ≥4)
Who cannot join
- Folic acid >400 mcg taken at any time during the study
- Psychotic features in the current episode or a history of psychotic features
- Any bipolar disorder (current or past) or any psychotic disorder (current or past)
- Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation
- Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination Deplin® and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis
This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.
- Conditions
- Major Depressive Disorder
- Being tested
- L-methylfolate, Selective serotonin reuptake inhibitor (SSRI), Serotonin and norepinephrine reuptake inhibitor (SNRI)
- Keywords
- Depression, Combination therapy, antidepressant, Deplin, folate, methylfolate
- 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.
L-methylfolateDrug
Also called Deplin
Subjects must have been on their respective therapies for a minimum of 60 days. L-methylfolate dosing was 7.5 mg or 15 mg daily
Selective serotonin reuptake inhibitor (SSRI)Drug
Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.
Serotonin and norepinephrine reuptake inhibitor (SNRI)Drug
Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.
| Study group | Role | What they receive |
|---|---|---|
| Deplin + antidepressant | Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) Receives: Drug: L-methylfolate; Drug: Selective serotonin reuptake inhibitor (SSRI); Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI) | |
| Antidepressant alone | SSRI or SNRI alone Receives: Drug: Selective serotonin reuptake inhibitor (SSRI); Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline
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.
Measured: 60 days
Secondary outcomes (3)
Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale
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.
Measured: 60 days
Number of Hospitalizations Due to MDD
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
Measured: 60 days
Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionJun 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamlab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Red Oak Psychiatry Associates, PA, Baylor Health Care System
- Responsible party
- Sponsor
- Investigators
- Lawrence D Ginsberg, MD, Principal investigator, Red Oak Psychiatry Associates, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001559
- Sponsor's protocol ID
- Pamlab D-005
- Status last verified
- Nov 2013
- First submitted
- 22 Oct 2009
- Last updated
- 19 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ginsberg LD, Oubre AY, Daoud YA. L-methylfolate Plus SSRI or SNRI from Treatment Initiation Compared to SSRI or SNRI Monotherapy in a Major Depressive Episode. Innov Clin Neurosci. 2011 Jan;8(1):19-28.
PubMed 21311704
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Deplin® and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT01001559
- Acronym / sponsor ID
- Pamlab D-005
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Combination therapy, antidepressant, Deplin, folate, methylfolate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Pamlab, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Red Oak Psychiatry Associates, PA, Baylor Health Care System
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Posted 19 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deplin + antidepressant | – | Drug: L-methylfolate, Drug: Selective serotonin reuptake inhibitor (SSRI), Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) |
| Antidepressant alone | – | Drug: Selective serotonin reuptake inhibitor (SSRI), Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)SSRI or SNRI alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ages 18-70 experiencing an episode of major depression
Key inclusion criteria (2 listed)
- Males or females age 18-70
- The active arm (Arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a CGI-S of ≥4 who began Deplin and SSRI or SNRI therapy at the same time beginning in January 2007 to the present; and, Control group (Arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began SSRI or SNRI therapy matched in severity (CGI-S of ≥4)
Key exclusion criteria (5 listed)
- Folic acid >400 mcg taken at any time during the study
- Psychotic features in the current episode or a history of psychotic features
- Any bipolar disorder (current or past) or any psychotic disorder (current or past)
- Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation
- Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks
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 |
|---|---|---|
| L-methylfolateAlso: DeplinSubjects must have been on their respective therapies for a minimum of 60 days. L-methylfolate dosing was 7.5 mg or 15 mg daily | Drug | Deplin + antidepressant |
| Selective serotonin reuptake inhibitor (SSRI)Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis. | Drug | Antidepressant alone, Deplin + antidepressant |
| Serotonin and norepinephrine reuptake inhibitor (SNRI)Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis. | Drug | Antidepressant alone, Deplin + antidepressant |
Primary outcome
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline
Time frame: 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.
3 secondary outcomes
Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale
Time frame: 60 days
Number of Hospitalizations Due to MDD
Time frame: 60 days
Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21311704Ginsberg LD, Oubre AY, Daoud YA. L-methylfolate Plus SSRI or SNRI from Treatment Initiation Compared to SSRI or SNRI Monotherapy in a Major Depressive Episode. Innov Clin Neurosci. 2011 Jan;8(1):19-28.
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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.
Lawrence D Ginsberg, MD principal investigator
Red Oak Psychiatry Associates, PA
1 site 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 1 site 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 2 inclusion and 5 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 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 19 Dec 2013). 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?
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline (time frame: 60 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 NCT01001559, which also lists 1 linked publication.
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 19 Dec 2013.