Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-02 @ 11:52 AM
Study NCT ID:
NCT02909504
Status:
TERMINATED
Last Update Posted:
2020-07-10
First Post:
2016-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gao NARASD Lithium Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008094', 'term': 'Lithium'}], 'ancestors': [{'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keming.gao@UHhospitals.org', 'phone': '2168442865', 'title': 'Dr. Keming Gao, MD, PhD', 'organization': 'University Hospitals Cleveland Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Lithium', 'description': 'Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \\> 0.6 mEq/L', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 20, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cognitive Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach Upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Daytime Sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Sexual Interest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lithium Non Responders', 'description': 'Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \\> 0.6 mEq/L.'}, {'id': 'OG001', 'title': 'Lithium Responders', 'description': 'Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \\> 0.6 mEq/L.'}], 'classes': [{'title': 'NLRP3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.73', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '26.00', 'spread': '7.25', 'groupId': 'OG001'}]}]}, {'title': 'PDEB4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.15', 'spread': '9.12', 'groupId': 'OG000'}, {'value': '27.31', 'spread': '5.78', 'groupId': 'OG001'}]}]}, {'title': 'BAK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.16', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '11.50', 'spread': '2.88', 'groupId': 'OG001'}]}]}, {'title': 'p-Fyn Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.49', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '6.44', 'groupId': 'OG001'}]}]}, {'title': 'HMGB1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.18', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '22.61', 'spread': '6.58', 'groupId': 'OG001'}]}]}, {'title': 'IRS2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.29', 'spread': '5.64', 'groupId': 'OG000'}, {'value': '24.06', 'spread': '8.71', 'groupId': 'OG001'}]}]}, {'title': 'p-CREB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.78', 'spread': '4.34', 'groupId': 'OG000'}, {'value': '30.46', 'spread': '6.55', 'groupId': 'OG001'}]}]}, {'title': 'PPAR g', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.90', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '21.13', 'spread': '5.62', 'groupId': 'OG001'}]}]}, {'title': 'TNFAIP3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.74', 'spread': '6.16', 'groupId': 'OG000'}, {'value': '31.17', 'spread': '6.64', 'groupId': 'OG001'}]}]}, {'title': 'TPH1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.13', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '7.23', 'spread': '2.47', 'groupId': 'OG001'}]}]}, {'title': 'PKC theta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.8', 'spread': '7.11', 'groupId': 'OG000'}, {'value': '35.81', 'spread': '8.71', 'groupId': 'OG001'}]}]}, {'title': 'Bcl-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.72', 'spread': '6.89', 'groupId': 'OG000'}, {'value': '35.87', 'spread': '8.94', 'groupId': 'OG001'}]}]}, {'title': 'iNOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.51', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '24.54', 'spread': '7.54', 'groupId': 'OG001'}]}]}, {'title': 'NR3C1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.33', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'mTor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.87', 'spread': '6.41', 'groupId': 'OG000'}, {'value': '21.07', 'spread': '8.60', 'groupId': 'OG001'}]}]}, {'title': 'PKA C-a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.51', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '23.93', 'spread': '7.08', 'groupId': 'OG001'}]}]}, {'title': 'Bcl-2 A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'BDNF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.78', 'spread': '6.72', 'groupId': 'OG000'}, {'value': '34.00', 'spread': '7.44', 'groupId': 'OG001'}]}]}, {'title': 'GSK-3b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.89', 'spread': '7.88', 'groupId': 'OG000'}, {'value': '19.49', 'spread': '6.47', 'groupId': 'OG001'}]}]}, {'title': 'XBP1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'MARCKS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'p-GSK 3b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.01', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '4.11', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'p-GSK 3ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.29', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Fyn', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.01', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '30.24', 'spread': '6.44', 'groupId': 'OG001'}]}]}, {'title': 'Timeless', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.41', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'PGM1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.96', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '28.58', 'spread': '6.64', 'groupId': 'OG001'}]}]}, {'title': 'NFKB p-P65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.03', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '14.58', 'spread': '8.01', 'groupId': 'OG001'}]}]}, {'title': 'Calmodulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.44', 'spread': '5.68', 'groupId': 'OG000'}, {'value': '31.86', 'spread': '7.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Molecule expression is measured as a function of relative fluorescence intensity. The number derives from a photomultiplier tube which essentially counts photons. Higher numbers mean a higher intensity. The values in the results tables represents change in fluorescence intensity between Baseline and Week 16 across various molecules of interest and compares responders (those who experience a \\>=50% decrease in mood symptom severity between baseline and week 16) and non responders (those who did NOT experience a \\>=50% decrease in mood symptom severity between baseline and week 16). The rows represent the various molecules that were analyzed.', 'unitOfMeasure': 'fluorescence intensity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'While we planned to analyze \\~45 molecules of interest, poor quality of antibodies to some proteins \\& financial limitations limited us to only 28 proteins. The number of participants analyzed for protein expression differs from baseline characteristic and varies below as not all subjects had high enough levels of a particular protein to be analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lithium', 'description': 'Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \\> 0.6 mEq/L'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Subject moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lithium', 'description': 'Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \\> 0.6 mEq/L'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '12.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Bipolar Diagnosis', 'classes': [{'categories': [{'title': 'Bipolar I Disorder', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Bipolar II Disorder', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lifetime Generalized Anxiety Disorder (GAD) Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lifetime Social Phobia Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lifetime Attention Deficit Hyperactivity Disorder (ADHD) Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-22', 'size': 470846, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-10-24T08:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-12', 'studyFirstSubmitDate': '2016-09-19', 'resultsFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-12', 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium', 'timeFrame': 'Baseline and Week 16', 'description': 'Molecule expression is measured as a function of relative fluorescence intensity. The number derives from a photomultiplier tube which essentially counts photons. Higher numbers mean a higher intensity. The values in the results tables represents change in fluorescence intensity between Baseline and Week 16 across various molecules of interest and compares responders (those who experience a \\>=50% decrease in mood symptom severity between baseline and week 16) and non responders (those who did NOT experience a \\>=50% decrease in mood symptom severity between baseline and week 16). The rows represent the various molecules that were analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'This study is a 4-month open-label study of lithium in the acute treatment of patients with bipolar I or II disorder. Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \\> 0.6 mEq/L. Blood samples are collected at baseline and at the end of study. Analyses of 45 molecule expressions in mononuclear blood cells at baseline and endpoint will be carried out after the completion of study. Fifty patients meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria for bipolar I or II will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor inclusion in this study, subjects must meet all of the following criteria:\n\n1. Able to provide informed consent before beginning any study-specific procedures;\n2. Male or female, 18-70 years old;\n3. Meets current DSM-5 criteria for bipolar I or II disorder as assessed by the The M.I.N.I. International Neuropsychiatric Interview (MINI);\n4. Any symptomatic phase of bipolar I or II disorder including, depressive, manic, mixed or hypomanic\n5. Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≥3;\n6. Willing to take lithium;\n7. If a sexually active female of childbearing potential, be using a reliable method of contraception;\n8. Women with reproductive potential must have a negative urine pregnancy test;\n9. Willing to have blood drawn:\n\nExclusion Criteria:\n\nAny of the following is regarded as a criterion for exclusion from the study:\n\n1. Unwilling to comply with study requirements;\n2. Renal impairment (serum creatinine \\>1.5 mg/dL);\n3. Thyroid stimulating hormone (TSH) over \\>20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1;\n4. Other contraindication to lithium,\n5. Patients who have had severe adverse reaction to Lithium;\n6. Patients who require inpatient care;\n7. Drug/alcohol dependence requiring immediate acute detoxification;\n8. Pregnancy as determined by serum pregnancy test or breastfeeding;\n9. History of nonresponse to lithium at doses ≥ 900 mg/d for ≥ 8 weeks;\n10. Unwilling to have blood drawn\n11. Patients with chronic medical conditions such as diabetes, coronary artery disease, immune diseases, infectious diseases and neurological disorders;\n12. Active suicidal ideation with a plan or intent, a suicide attempt within past 6 months or more than 2 suicide attempts within the past 2 years.\n13. Currently on lithium'}, 'identificationModule': {'nctId': 'NCT02909504', 'briefTitle': 'Gao NARASD Lithium Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Biomarkers in Mononuclear Blood Cells for Lithium Treatment Response of Bipolar Disorder', 'orgStudyIdInfo': {'id': '07-16-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lithium', 'description': 'Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \\> 0.6 mEq/L', 'interventionNames': ['Drug: Lithium']}], 'interventions': [{'name': 'Lithium', 'type': 'DRUG', 'description': 'Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \\> 0.6 mEq/L', 'armGroupLabels': ['Lithium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center Department of Psychiatry', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Keming Gao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keming Gao', 'class': 'OTHER'}, 'collaborators': [{'name': 'CellPrint Biotechnology', 'class': 'OTHER'}, {'name': 'National Alliance for Research on Schizophrenia and Depression', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Director, Mood Disorders Program, UH Cleveland Medical Center', 'investigatorFullName': 'Keming Gao', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}