Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT00250705
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2005-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Aripiprazole in the Treatment of CD in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019955', 'term': 'Conduct Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Samuel-Kuperman@uiowa.edu', 'phone': '319-356-1482', 'title': 'An Open Label Trial of Aripiprazole in the Treatment of Conduct Disorder in Adolescents.', 'organization': 'The University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '12 subjects were recruited for this study but only 10 (83%) completed at least a week of data demonstrating the primary frustrations of the investigators in this study. Conduct disorder was a difficult diagnosis to recruit patients into this study.'}}, 'adverseEventsModule': {'timeFrame': 'Subjects were enrolled for a 6 week study.', 'description': 'Safety measures for extrapyramidal ADRs included the AIMS (NIMH, 1985b) for tardive dyskinesia Barnes Akathisia Scale (Barnes 1989) (BAS) and the Simpson-Angus Scale (SAS) for parkinsonian movements (Simpson and Angus 1970). The UKU (Lingjaerde et al 1987) was used for monitoring non-motor ADRs.', 'eventGroups': [{'id': 'EG000', 'title': 'Aripiprazole in the Treatment of Conduct Disorder', 'description': 'The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fatigue', 'notes': 'Increased fatigue, sleepiness-sedation, increased sleep duration, or decreased sleep duration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 29, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'sedation'}, {'term': 'muscle rigidity', 'notes': 'parkinsonian type symptoms of stiff muscles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'AIM'}, {'term': 'tremor', 'notes': 'tremor of extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'AIM'}, {'term': 'akathisia', 'notes': 'motor restlessness, increased pacing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'AIM'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'UKU Scale'}, {'term': 'Increase perspiraton', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'UKU scale'}, {'term': 'Head Aches', 'notes': 'patient report on questionnaire', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'UKU'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Visit weight'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Treatment of Conduct Disorder', 'description': 'The study was a 6-week open label study evaluating aripiprazole in the treatment of 10 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000). The initial aripiprazole dose depending on the weight of the patient was: \\< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \\> 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose was individualized based on the response and tolerance to the drug with a maximum aripiprazole dose of 20 mg/d. Current psychotropic medications were not washed out of the patients at the beginning of the study due to the exploratory stage of use of the drug for the conduct disorder indication.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) is a global rating scale of aggression completed by clinicians. Score given based on following severity scale with subject assigned 1 number: Intolerable behavior-frequently physically attacks others and destroys property (5); Severe-occasionally physically attacks people and destroys property (4); Moderately 21); and No aggressiveness reported (1). A minimum score of 1 is best and a maximum score of 5 is worst. There are no subscale scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Overt Aggression Scale-Modified (OAS-M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescent Conduct Disorder Males', 'description': 'All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.\n\nAripiprazole: The initial dose depending on the weight of the patient will be as follows: \\< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \\> 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. The dose was individualized based on response and tolerance with a maximum of 20 mg per day.'}], 'classes': [{'title': 'verbal aggression', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'property aggression', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'self aggression', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'physical aggression', 'categories': [{'measurements': [{'value': '1.6', 'spread': '3.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'OAS-M divides aggressions into 4 subtypes: 1) verbal aggression, 2) property aggression, 3) self aggression (autoaggression), and 4) physical aggression. Each subtype has an initial score ranging from 0 (least aggressive) to 4 (most aggressive). The score for each subscale is further weighed (multiplied) by a constant: verbal scale\'s constant is 1 (max adjusted score of 4); property scale\'s constant is 2 (max adjusted score 8); self scale\'s constant is 3 (max adjusted score 12); and physical scale\'s constant is 4 (max adjusted score of 16). Within a given scale, "0" is the best score and maximum adjusted scale score is worst.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Treatment of Conduct Disorder', 'description': 'The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1. Normal, not at all ill; 2. Borderline mentally ill, 3. Mildly ill; 4. Moderately ill; 5. Markedly ill; 6. Severely ill; or 7. Among the most extremely ill patients.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Aggression Scale-Parent Version", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescent Conduct Disorder Males', 'description': 'All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.\n\nAripiprazole: The initial dose depending on the weight of the patient will be as follows: \\< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \\> 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. The dose was individualized based on response and tolerance with a maximum of 20 mg per day.'}], 'classes': [{'title': 'Verbal Aggression', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Aggression Against Objects and Animals', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Provoked Aggression', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Initiated Aggression', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Aggression with Use of Weapons', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'CAS-P is a 33 item scale representing 5 domains of aggression: Items in a domain were computed based on two reference points. The first was based on a 5 point frequency range with "0" being best (never) and "4" (\\> 10 times being) worst. These same items were then adjusted such that more severe acts would be weighted more heavily compared to less severe aggressive behaviors. Within a domain, 0 was the best score. Worst score for the various aggression domains were: Verbal 26.16, Against Objects and Animals 11.8, Provoked 15.84, Initiated 17.84, and Use of Weapons 13.16.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Treatment of Conduct Disorder', 'description': 'The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved; 2. Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; or 7. Much worse)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aripiprazole Treatment of Conduct Disorde', 'description': 'The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000). The initial aripiprazole dose depending on the weight of the patient was: \\< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \\> 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose was individualized based on the response and tolerance to the drug with a maximum aripiprazole dose of 20 mg/d. Current psychotropic medications were not washed out of the patients at the beginning of the study due to the exploratory stage of use of the drug for the conduct disorder indication.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were recruited through the child psychiatric clinic after being identified as diagnosed with DSM 4 conduct disorder. Subjects and their parents were approached about participation in the study. Recruitment time was November 2004 through March 2009', 'preAssignmentDetails': 'The study was an open label study with no separate treatment groups, i.e., different doses or placebo. All subjects that were enrolled into participation were entered into active treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aripiprazole Treatment of Conduct Disorder', 'description': 'The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Rating of Aggression Against People and/or Property Scale', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) is a global rating scale of aggression completed by clinicians. Score given based on following severity scale with subject assigned 1 number: Intolerable behavior-frequently physically attacks others and destroys property (5); Severe-occasionally physically attacks people and destroys property (4); Moderately 21); and No aggressiveness reported (1). A minimum score of 1 is best and a maximum score of 5 is worst. There are no subscale scores.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '10 subjects who completed the study with last visit carried forward for two.'}, {'title': 'Overt Aggression Scale-Modified (OAS-M) (Kay et al 1988)', 'classes': [{'title': 'OAS-M, verbal aggression', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.2', 'groupId': 'BG000'}]}]}, {'title': 'OAS-M, aggression against property', 'categories': [{'measurements': [{'value': '4.2', 'spread': '3.0', 'groupId': 'BG000'}]}]}, {'title': 'OAS-M, autoaggression', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.9', 'groupId': 'BG000'}]}]}, {'title': 'OAS-M, physical aggression', 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'OAS-M divides aggressions into 4 subtypes: 1) verbal, 2) property, 3) self (autoaggression), and 4) physical. Each subtype has an initial score ranging from 0 (least aggressive) to 4 (most aggressive). The score for each subscale is further weighed (multiplied) by a constant: verbal scale\'s constant is 1 (max adjusted score of 4); property scale\'s constant is 2 (max adjusted score 8); self scale\'s constant is 3 (max adjusted score 12); and physical scale\'s constant is 4 (max adjusted score of 16). Within a given scale, "0" is the best score and maximum adjusted scale score is worst.', 'unitOfMeasure': 'weighted scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Children's Aggression Scale-Parent Version", 'classes': [{'title': 'Verbal Aggression', 'categories': [{'measurements': [{'value': '12.9', 'spread': '4.3', 'groupId': 'BG000'}]}]}, {'title': 'Agression Against Objects and Animals', 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.2', 'groupId': 'BG000'}]}]}, {'title': 'Provoked Aggression', 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.2', 'groupId': 'BG000'}]}]}, {'title': 'Initiated Aggression', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.0', 'groupId': 'BG000'}]}]}, {'title': 'Use of Weapons', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'CAS-P is a 33 item scale representing 5 domains of aggression: Items in a domain were computed based on two reference points. The first was based on a 5 point frequency range with "0" being best (never) and "4" (\\> 10 times being) worst. These same items were then adjusted such that more severe acts would be weighted more heavily compared to less severe aggressive behaviors. Within a domain, 0 was the best score. Worst score for the various aggression domains were: Verbal 26.16, Against Objects and Animals 11.8, Provoked 15.84, Initiated 17.84, and Use of Weapons 13.16', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2004-05-23', 'size': 351949, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-07-05T10:44', 'hasProtocol': True}, {'date': '2004-05-23', 'size': 115295, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-07-05T10:44', 'hasProtocol': False}, {'date': '2004-05-23', 'size': 305868, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-07-05T10:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2009-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-06', 'studyFirstSubmitDate': '2005-11-04', 'resultsFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2005-11-04', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-06', 'studyFirstPostDateStruct': {'date': '2005-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)', 'timeFrame': '6 weeks', 'description': 'Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) is a global rating scale of aggression completed by clinicians. Score given based on following severity scale with subject assigned 1 number: Intolerable behavior-frequently physically attacks others and destroys property (5); Severe-occasionally physically attacks people and destroys property (4); Moderately 21); and No aggressiveness reported (1). A minimum score of 1 is best and a maximum score of 5 is worst. There are no subscale scores.'}, {'measure': 'Overt Aggression Scale-Modified (OAS-M)', 'timeFrame': '6 weeks', 'description': 'OAS-M divides aggressions into 4 subtypes: 1) verbal aggression, 2) property aggression, 3) self aggression (autoaggression), and 4) physical aggression. Each subtype has an initial score ranging from 0 (least aggressive) to 4 (most aggressive). The score for each subscale is further weighed (multiplied) by a constant: verbal scale\'s constant is 1 (max adjusted score of 4); property scale\'s constant is 2 (max adjusted score 8); self scale\'s constant is 3 (max adjusted score 12); and physical scale\'s constant is 4 (max adjusted score of 16). Within a given scale, "0" is the best score and maximum adjusted scale score is worst.'}, {'measure': "Children's Aggression Scale-Parent Version", 'timeFrame': '6 weeks', 'description': 'CAS-P is a 33 item scale representing 5 domains of aggression: Items in a domain were computed based on two reference points. The first was based on a 5 point frequency range with "0" being best (never) and "4" (\\> 10 times being) worst. These same items were then adjusted such that more severe acts would be weighted more heavily compared to less severe aggressive behaviors. Within a domain, 0 was the best score. Worst score for the various aggression domains were: Verbal 26.16, Against Objects and Animals 11.8, Provoked 15.84, Initiated 17.84, and Use of Weapons 13.16.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).', 'timeFrame': '6 weeks', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1. Normal, not at all ill; 2. Borderline mentally ill, 3. Mildly ill; 4. Moderately ill; 5. Markedly ill; 6. Severely ill; or 7. Among the most extremely ill patients."}, {'measure': 'Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).', 'timeFrame': '6 weeks', 'description': "The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved; 2. Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; or 7. Much worse)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aripiprazole'], 'conditions': ['Conduct Disorder']}, 'referencesModule': {'references': [{'pmid': '22073384', 'type': 'RESULT', 'citation': 'Kuperman S, Calarge C, Kolar A, Holman T, Barnett M, Perry P. An open-label trial of aripiprazole in the treatment of aggression in male adolescents diagnosed with conduct disorder. Ann Clin Psychiatry. 2011 Nov;23(4):270-6.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder. The initial dose depending on the weight of the patient will be as follows: \\< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \\> 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). For the first two weeks of the study, the dose will be flexible based on response and tolerance and thereafter will remain fixed.', 'detailedDescription': "The use of atypical antipsychotics in children began in 1992 with several small case series with clozapine. Since that time, five other atypical agents, risperidone, olanzapine, quetiapine, ziprasidone and aripiprazole have been introduced into the US market. The newer atypical agents are not associated with agranulocytosis that has limited the usefulness of clozapine. Among the atypical antipsychotics, risperidone has remained the most extensively studied in children and adolescents, for a variety of problems, including Tourette's disorder, conduct disorder, schizophrenia, aggression, and pervasive development disorder. Risperidone has been shown to be an effective treatment in many of these disorders. However, weight gain, hyperprolactinemia, and extrapyramidal symptoms (EPS) are troublesome adverse effects more commonly associated with risperidone such that the drug's utility in this aged patient population is limited. We expect that the utility of aripiprazole in treating the pediatric population will not be limited by adverse effects like the other atypical antipsychotics."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder.\n\nExclusion Criteria:\n\n* Clinically significant laboratory and/or ECG abnormalities\n* Pre-existing health conditions that would compromise patient safety\n* Mental retardation\n* Previous use of aripiprazole\n* Active psychosis'}, 'identificationModule': {'nctId': 'NCT00250705', 'briefTitle': 'Trial of Aripiprazole in the Treatment of CD in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Open Label Trial of Aripiprazole in the Treatment of CD in Adolescents', 'orgStudyIdInfo': {'id': '200306035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adolescent Conduct Disorder Males', 'description': 'All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.', 'interventionNames': ['Drug: Aripiprazole']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify'], 'description': 'The initial dose depending on the weight of the patient will be as follows: \\< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \\> 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.', 'armGroupLabels': ['Adolescent Conduct Disorder Males']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'The University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Samuel Kuperman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Samuel Kuperman, M.D.', 'investigatorAffiliation': 'University of Iowa'}}}}