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
|Condition or disease||Intervention/treatment||Phase|
|Conduct Disorder||Drug: Aripiprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label trial|
|Masking:||None (Open Label)|
|Official Title:||Open Label Trial of Aripiprazole in the Treatment of CD in Adolescents|
|Actual Study Start Date :||November 17, 2004|
|Actual Primary Completion Date :||March 23, 2009|
|Actual Study Completion Date :||March 23, 2009|
Adolescent Conduct Disorder Males
All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with 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. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.
Other Name: Abilify
- The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) [ Time Frame: 6 weeks ]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.
- Overt Aggression Scale-Modified (OAS-M) [ Time Frame: 6 weeks ]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.
- Children's Aggression Scale-Parent Version [ Time Frame: 6 weeks ]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.
- Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a). [ Time Frame: 6 weeks ]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.
- Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a). [ Time Frame: 6 weeks ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250705
|United States, Iowa|
|The University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Samuel Kuperman, M.D.||University of Iowa|