Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT00405535
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2006-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjunctive Glycine for Obsessive Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005998', 'term': 'Glycine'}], 'ancestors': [{'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2006-11-28', 'studyFirstSubmitQcDate': '2006-11-28', 'lastUpdatePostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Y-BOCS (Yale-Brown Obsessive Compulsive Scale)', 'timeFrame': '12 weeks after baseline'}], 'secondaryOutcomes': [{'measure': 'NIMC-OC scale', 'timeFrame': '12 weeks after baseline'}, {'measure': 'CGI-Improvement', 'timeFrame': '12 weeks after baseline'}, {'measure': 'QLS(Quality of Life Scale)', 'timeFrame': '12 weeks after baseline'}, {'measure': 'Sheehan Disability Scale', 'timeFrame': '12 weeks after baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OCD', 'Obsessive Compulsive Disorder', 'Glycine'], 'conditions': ['Obsessive Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '19046587', 'type': 'DERIVED', 'citation': 'Greenberg WM, Benedict MM, Doerfer J, Perrin M, Panek L, Cleveland WL, Javitt DC. Adjunctive glycine in the treatment of obsessive-compulsive disorder in adults. J Psychiatr Res. 2009 Mar;43(6):664-70. doi: 10.1016/j.jpsychires.2008.10.007. Epub 2008 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether individuals with obsessive compulsive disorder who will take a preparation of the amino acid glycine in addition to their current treatment, may experience improvement in their symptoms.', 'detailedDescription': 'Individuals with obsessive compulsive disorder (OCD) often find inadequate relief, even with the best of currently available treatments. Some evidence suggests the the neurotransmitter glutamate may be a useful target for new treatments for OCD. The amino acid glycine, if given orally in adequate dosages, can have specific effects on one particular glutamate receptor molecule in the brain, that might be helpful with OC symptoms. This randomized, double-blind protocol will have study participants who suffer with OCD take either a glycine preparation or placebo for 12 weeks. Clinical measures (e.g., Y-BOCS, NIMH-OC) will be recorded at each visit to determine whether those taking the glycine experience clinical benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of OCD present for at least 1 year\n* Male or female, age 18 to 65\n* Stable medication regimen for 12 weeks prior to study entry\n* at least moderately severe OC symptoms\n\nExclusion Criteria:\n\n* Active substance use disorder within the last 6 months\n* Comorbid schizophrenia, schizoaffective disorder, bipolar disorder, tic disorder, Tourette Disorder, schizotypal personality disorder\n* Hoarding as the principal OCD symptom\n* Insulin-dependent diabetes mellitus\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00405535', 'briefTitle': 'Adjunctive Glycine for Obsessive Compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Nathan Kline Institute for Psychiatric Research'}, 'officialTitle': 'Adjunctive Glycine for Obsessive Compulsive Disorder', 'orgStudyIdInfo': {'id': '04I/C06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'glycine powder', 'interventionNames': ['Drug: glycine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'placebo powder', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'glycine', 'type': 'DRUG', 'armGroupLabels': ['A']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10962', 'city': 'Orangeburg', 'state': 'New York', 'country': 'United States', 'facility': 'The Nathan Kline Institute for Psychiatric Research', 'geoPoint': {'lat': 41.04649, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'William M Greenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nathan Kline Institute for Psychiatric Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nathan Kline Institute for Psychiatric Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Obsessive Compulsive Foundation', 'class': 'OTHER'}]}}}