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Trial record 53 of 408 for:    ARIPIPRAZOLE

Trial of Aripiprazole in the Treatment of CD in Adolescents

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ClinicalTrials.gov Identifier: NCT00250705
Recruitment Status : Completed
First Posted : November 8, 2005
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Samuel Kuperman, M.D., University of Iowa

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Conduct Disorder
Intervention Drug: Aripiprazole
Enrollment 12
Recruitment Details 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
Pre-assignment Details 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.
Arm/Group Title Aripiprazole Treatment of Conduct Disorde
Hide Arm/Group 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.
Period Title: Overall Study
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Lack of Efficacy             2
Arm/Group Title Aripiprazole Treatment of Conduct Disorder
Hide Arm/Group 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).
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
10
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
14.6  (1.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
0
   0.0%
Male
10
 100.0%
Rating of Aggression Against People and/or Property Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 10 participants
3.0  (0.9)
[1]
Measure 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.
[2]
Measure Analysis Population Description: 10 subjects who completed the study with last visit carried forward for two.
Overt Aggression Scale-Modified (OAS-M) (Kay et al 1988)   [1] 
Mean (Standard Deviation)
Unit of measure:  Weighted scores on a scale
Number Analyzed 10 participants
OAS-M, verbal aggression 2.2  (1.2)
OAS-M, aggression against property 4.2  (3.0)
OAS-M, autoaggression 0.6  (1.9)
OAS-M, physical aggression 4.5  (3.9)
[1]
Measure 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.
Children's Aggression Scale-Parent Version   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants
Verbal Aggression 12.9  (4.3)
Agression Against Objects and Animals 3.8  (2.2)
Provoked Aggression 2.1  (2.2)
Initiated Aggression 1.6  (2.0)
Use of Weapons 0.4  (1.0)
[1]
Measure 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
1.Primary Outcome
Title The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)
Hide 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Aripiprazole Treatment of Conduct Disorder
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.7  (0.8)
2.Primary Outcome
Title Overt Aggression Scale-Modified (OAS-M)
Hide 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Adolescent Conduct Disorder Males
Hide Arm/Group Description:

All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.

Aripiprazole: 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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
verbal aggression 1.0  (1.2)
property aggression 0.6  (1.9)
self aggression 0.6  (1.9)
physical aggression 1.6  (3.9)
3.Primary Outcome
Title Children's Aggression Scale-Parent Version
Hide 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Adolescent Conduct Disorder Males
Hide Arm/Group Description:

All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.

Aripiprazole: 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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Verbal Aggression 2.7  (2.8)
Aggression Against Objects and Animals 0.4  (0.8)
Provoked Aggression 1.6  (0.5)
Initiated Aggression 0.6  (1.2)
Aggression with Use of Weapons 0.1  (0.3)
4.Secondary Outcome
Title Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).
Hide 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Treatment of Conduct Disorder
Hide Arm/Group 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).
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.0  (1.5)
5.Secondary Outcome
Title Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).
Hide 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)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Treatment of Conduct Disorder
Hide Arm/Group 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).
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.1  (1.4)
Time Frame Subjects were enrolled for a 6 week study.
Adverse Event Reporting 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.
 
Arm/Group Title Aripiprazole in the Treatment of Conduct Disorder
Hide Arm/Group 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).
All-Cause Mortality
Aripiprazole in the Treatment of Conduct Disorder
Affected / at Risk (%)
Total   0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole in the Treatment of Conduct Disorder
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole in the Treatment of Conduct Disorder
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Gastrointestinal disorders   
Nausea/Vomiting  3  5/10 (50.00%) 
General disorders   
fatigue  1 [1]  10/10 (100.00%)  29
Metabolism and nutrition disorders   
Weight Gain  5  4/10 (40.00%) 
Nervous system disorders   
muscle rigidity  2 [2]  4/10 (40.00%) 
tremor  2 [3]  3/10 (30.00%) 
akathisia  2 [4]  5/10 (50.00%) 
Head Aches  4 [5]  9/10 (90.00%) 
Skin and subcutaneous tissue disorders   
Increase perspiraton  3  6/10 (60.00%) 
1
Term from vocabulary, sedation
2
Term from vocabulary, AIM
3
Term from vocabulary, UKU Scale
4
Term from vocabulary, UKU
5
Term from vocabulary, Visit weight
Indicates events were collected by systematic assessment
[1]
Increased fatigue, sleepiness-sedation, increased sleep duration, or decreased sleep duration
[2]
parkinsonian type symptoms of stiff muscles
[3]
tremor of extremities
[4]
motor restlessness, increased pacing
[5]
patient report on questionnaire
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: An Open Label Trial of Aripiprazole in the Treatment of Conduct Disorder in Adolescents.
Organization: The University of Iowa
Phone: 319-356-1482
EMail: Samuel-Kuperman@uiowa.edu
Layout table for additonal information
Responsible Party: Samuel Kuperman, M.D., University of Iowa
ClinicalTrials.gov Identifier: NCT00250705     History of Changes
Other Study ID Numbers: 200306035
First Submitted: November 4, 2005
First Posted: November 8, 2005
Results First Submitted: March 28, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017