Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT00737204
Status:
COMPLETED
Last Update Posted:
2014-06-12
First Post:
2008-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077408', 'term': 'Modafinil'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgr1@columbia.edu', 'phone': '(646) 774-8075', 'title': 'Judith G. Rabkin, Ph.D., M.P.H.', 'organization': 'New York State Psychiatric Institute'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent side effects were assessed at baseline and then weekly during the 4-week trial.', 'description': 'Each potential side effect was rated on a 0 ("No Problems" to 5 ("Severe Problems"). An increase of 2 points during the trial from the baseline score was considered an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Armodafinil', 'description': 'Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fatigue Severity Scale(FSS) Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Armodafinil', 'description': 'Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.'}], 'classes': [{'title': 'Baseline FSS', 'categories': [{'measurements': [{'value': '52.6', 'spread': '6.13', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '6.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 FSS', 'categories': [{'measurements': [{'value': '25.8', 'spread': '14.23', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '14.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and Weeks 4', 'description': 'The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 70 patients randomized, 64 completed the 4-week trial. Data presented are for the 70, using the last data point carried forward (intention to treat).'}, {'type': 'PRIMARY', 'title': 'Role Function Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Armodafinil', 'description': 'Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.'}], 'classes': [{'title': 'Baseline Role Function Scale', 'categories': [{'measurements': [{'value': '36.2', 'spread': '5.75', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '7.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Role Function Scale', 'categories': [{'measurements': [{'value': '19.9', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '10.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Repeated measure analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 4', 'description': 'The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The week 4 outcome analyses are based on an intention to treat sample, which includes the 6 dropouts, using the last data point brought forward.'}, {'type': 'SECONDARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Armodafinil', 'description': 'Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.'}], 'classes': [{'title': 'Baseline CD4 cell count', 'categories': [{'measurements': [{'value': '502', 'spread': '202', 'groupId': 'OG000'}, {'value': '450', 'spread': '241', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 CD4 cell count', 'categories': [{'measurements': [{'value': '503', 'spread': '224', 'groupId': 'OG000'}, {'value': '445', 'spread': '255', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>=.805', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: CD4 levels for both the Armodafinil and Placebo groups will not change significantly between baseline and week 4.', 'statisticalMethod': 'Paired t-tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and Week 4', 'description': 'Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of \\>=100 cells. A higher number is associated with better immune functioning.', 'unitOfMeasure': 'Cells/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were included for patients on whom baseline and week 4 labs were drawn.'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Armodafinil', 'description': 'Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.'}], 'classes': [{'title': 'Baseline Log10 Viral Load', 'categories': [{'measurements': [{'value': '2.17', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Log10 Viral load', 'categories': [{'measurements': [{'value': '2.15', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and Week 4', 'description': 'HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated "under 50 copies," which was the assay\'s lowest limit of detectability during the study.', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were included for patients on whom baseline and week 4 labs were drawn.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Armodafinil', 'description': 'Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Patients were recruited from community based organizations and healthcare clinics that provide services to persons with HIV, by placing flyers on bulletin boards and in waiting areas.', 'preAssignmentDetails': 'A total of 114 patients were screened for eligibility, 25 had medical or psychiatric exclusion criteria, 7 were active substance users, 4 were taking stimulants, 3 were not clinically fatigued, 5 declined participation, and 70 were randomized. Of the 70, 64 completed the 4-week trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Armodafinil', 'description': 'Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '46', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '46', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-11', 'studyFirstSubmitDate': '2008-08-14', 'resultsFirstSubmitDate': '2013-03-13', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-11', 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale(FSS) Outcome', 'timeFrame': 'Measured at baseline and Weeks 4', 'description': 'The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.'}, {'measure': 'Role Function Scale', 'timeFrame': 'Measured at Baseline and Week 4', 'description': 'The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.'}], 'secondaryOutcomes': [{'measure': 'CD4 Cell Count', 'timeFrame': 'Measured at baseline and Week 4', 'description': 'Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of \\>=100 cells. A higher number is associated with better immune functioning.'}, {'measure': 'HIV Viral Load', 'timeFrame': 'Measured at baseline and Week 4', 'description': 'HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated "under 50 copies," which was the assay\'s lowest limit of detectability during the study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'AIDS', 'Armodafinil', 'Depression'], 'conditions': ['HIV Infections', 'Fatigue']}, 'referencesModule': {'references': [{'pmid': '15641875', 'type': 'BACKGROUND', 'citation': 'Rabkin JG, McElhiney MC, Rabkin R, Ferrando SJ. Modafinil treatment for fatigue in HIV+ patients: a pilot study. J Clin Psychiatry. 2004 Dec;65(12):1688-95. doi: 10.4088/jcp.v65n1215.'}, {'pmid': '21777715', 'type': 'RESULT', 'citation': 'Rabkin JG, McElhiney MC, Rabkin R. Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial. Psychosomatics. 2011 Jul-Aug;52(4):328-36. doi: 10.1016/j.psym.2011.02.005.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.', 'detailedDescription': 'Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be caused by ARVs or by the virus itself. A related study tested whether modafinil, of which armodafinil is an r-isomer, could reduce fatigue in HIV/AIDS patients. Armodafinil, believed to have a longer duration and greater effect than modafinil, will be tested on the same criteria.\n\nParticipants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants randomized to active medication and who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks. For these participants, the study duration is 20 weeks. Participants who did not benefit from armodafinil will receive alternate treatment options. All participants will have weekly study visits for the first 4 weeks of the study and biweekly visits for the remainder of the study. At each visit, participants will complete various tasks to determine cognitive function, and self-report scales will be used to determine symptoms of depression and fatigue. After completion of 16 weeks, participants responding to armodafinil will be transitioned to the publicly available modafinil over the course of 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 18-75\n2. HIV+\n3. Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)\n4. Fatigue duration for 3+ months\n5. English-speaking\n6. Able to give informed consent\n7. Fecund women uses barrier method of contraception\n\nExclusion Criteria:\n\n1. Primary care doctor does not approve of study participation\n2. Unstable medical condition (e.g. liver failure; cirrhosis, new onset opportunistic infection in past month)\n3. Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)\n4. Untreated hypothyroidism (Thyroid Stimulating Hormone over 5 IUI/mL)\n5. Untreated and uncontrolled hypertension\n6. Clinically significant anemia (hematocrit \\<30%)\n7. Started testosterone or nandrolone in past 6 weeks\n8. Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months\n9. Untreated or under-treated major depressive disorder\n10. Started antidepressant medication within past 6 weeks\n11. Substance abuse/dependence (past 4 months)\n12. Regular and frequent cannabis use (\\> twice/week regularly)\n13. Currently clinically significant suicidal ideation or Hamilton Depression Scale (HAM-D) score \\>24\n14. History or current psychosis or bipolar disorder\n15. Pregnant or breastfeeding\n16. Significant untreated insomnia (score \\>3 on HAM-D insomnia items)\n17. Currently taking psychostimulant medication or past nonresponse to modafinil\n18. Has no alternative viable antiretroviral regimen after the current one\n19. Left ventricular hypertrophy; mitral valve prolapse'}, 'identificationModule': {'nctId': 'NCT00737204', 'briefTitle': 'Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Armodafinil Treatment for Fatigue in HIV+ Patients', 'orgStudyIdInfo': {'id': '#4839/5892R'}, 'secondaryIdInfos': [{'id': 'R01MH072383-02', 'link': 'https://reporter.nih.gov/quickSearch/R01MH072383-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Armodafinil', 'description': 'Participants will take armodafinil for 4 weeks. The dose will be titrated up from 50mg to 250mg per day as clinically indicated, using 50mg tablets. If responsive, participants will be offered 12 additional weeks of armodafinil.', 'interventionNames': ['Drug: Armodafinil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo pills for 4 weeks. Placebo tablets that match the 50mg active medication tablets will given following the same dosing strategy as Arm 1. The dose will be titrated from 1 placebo tablet daily to 5 tablets daily as clinically indicated. Non-responders to placebo will then be offered 16 weeks of active medication.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Armodafinil', 'type': 'DRUG', 'otherNames': ['Nuvigil'], 'description': 'Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.', 'armGroupLabels': ['Armodafinil']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Judith G. Rabkin, Phd, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}