Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 5:17 AM
Study NCT ID:
NCT01001559
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2009-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005984', 'term': '5-methyltetrahydrofolate'}, {'id': 'D017367', 'term': 'Selective Serotonin Reuptake Inhibitors'}, {'id': 'D000068760', 'term': 'Serotonin and Noradrenaline Reuptake Inhibitors'}], 'ancestors': [{'id': 'D014179', 'term': 'Neurotransmitter Uptake Inhibitors'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D018490', 'term': 'Serotonin Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'larrydg@earthlink.net', 'phone': '281-893-4111', 'title': 'Dr. Lawrence Ginsberg', 'phoneExt': '151', 'organization': 'Red Oak Psychiatry Associates'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AE reporting occurred between January 2007 and September 2009', 'eventGroups': [{'id': 'EG000', 'title': 'Deplin + Antidepressant', 'description': 'Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)', 'otherNumAtRisk': 93, 'otherNumAffected': 56, 'seriousNumAtRisk': 93, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Antidepressant Alone', 'description': 'SSRI or SNRI alone', 'otherNumAtRisk': 103, 'otherNumAffected': 68, 'seriousNumAtRisk': 103, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Sexual Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': '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.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deplin + Antidepressant', 'description': 'Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)'}, {'id': 'OG001', 'title': 'Antidepressant Alone', 'description': 'SSRI or SNRI alone'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', '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.\n\nNumber of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deplin + Antidepressant', 'description': 'Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)'}, {'id': 'OG001', 'title': 'Antidepressant Alone', 'description': 'SSRI or SNRI alone'}], 'classes': [{'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '299'}, {'value': '231', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '540'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '60 days', '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.\n\nMedian 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.", 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalizations Due to MDD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deplin + Antidepressant', 'description': 'Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)'}, {'id': 'OG001', 'title': 'Antidepressant Alone', 'description': 'SSRI or SNRI alone'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', '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', 'unitOfMeasure': 'Hospitalizations due to MDD', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deplin + Antidepressant', 'description': 'Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)'}, {'id': 'OG001', 'title': 'Antidepressant Alone', 'description': 'SSRI or SNRI alone'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'unitOfMeasure': 'Alterations in antidepressant therapy', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Deplin + Antidepressant', 'description': 'Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)'}, {'id': 'FG001', 'title': 'Antidepressant Alone', 'description': 'SSRI or SNRI alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Deplin + Antidepressant', 'description': 'Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)'}, {'id': 'BG001', 'title': 'Antidepressant Alone', 'description': 'SSRI or SNRI alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '43.0', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-25', 'studyFirstSubmitDate': '2009-10-22', 'resultsFirstSubmitDate': '2013-04-19', 'studyFirstSubmitQcDate': '2009-10-23', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-25', 'studyFirstPostDateStruct': {'date': '2009-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline', 'timeFrame': '60 days', '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.\n\nNumber of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline."}], 'secondaryOutcomes': [{'measure': 'Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale', 'timeFrame': '60 days', '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.\n\nMedian 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."}, {'measure': 'Number of Hospitalizations Due to MDD', 'timeFrame': '60 days', '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'}, {'measure': 'Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Combination therapy', 'antidepressant', 'Deplin', 'folate', 'methylfolate'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '21311704', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults ages 18-70 experiencing an episode of major depression', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females age 18-70\n* 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)\n\nExclusion Criteria:\n\n* Folic acid \\>400 mcg taken at any time during the study\n* Psychotic features in the current episode or a history of psychotic features\n* Any bipolar disorder (current or past) or any psychotic disorder (current or past)\n* Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation\n* Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks'}, 'identificationModule': {'nctId': 'NCT01001559', 'briefTitle': 'Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pamlab, Inc.'}, 'officialTitle': 'Combination Deplin® and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis', 'orgStudyIdInfo': {'id': 'Pamlab D-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Deplin + antidepressant', 'description': 'Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)', 'interventionNames': ['Drug: L-methylfolate', 'Drug: Selective serotonin reuptake inhibitor (SSRI)', 'Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)']}, {'label': 'Antidepressant alone', 'description': 'SSRI or SNRI alone', 'interventionNames': ['Drug: Selective serotonin reuptake inhibitor (SSRI)', 'Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)']}], 'interventions': [{'name': 'L-methylfolate', 'type': 'DRUG', 'otherNames': ['Deplin'], 'description': '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', 'armGroupLabels': ['Deplin + antidepressant']}, {'name': 'Selective serotonin reuptake inhibitor (SSRI)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Antidepressant alone', 'Deplin + antidepressant']}, {'name': 'Serotonin and norepinephrine reuptake inhibitor (SNRI)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Antidepressant alone', 'Deplin + antidepressant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Red Oak Psychiatry Associates, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lawrence D Ginsberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Red Oak Psychiatry Associates, PA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamlab, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Red Oak Psychiatry Associates, PA', 'class': 'UNKNOWN'}, {'name': 'Baylor Health Care System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}