Conduct DisorderPhase 4NCT00250705

Trial of Aripiprazole in the Treatment of CD in Adolescents

A Phase 4 study testing Aripiprazole in people with Conduct Disorder, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 17 years, men onlyHealthy volunteers can take part
Conditions the study is for: Conduct Disorder
What is being tested?: Aripiprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 17 Nov 2004to 23 Mar 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 17 years
Men only
Healthy volunteers accepted
Child

Who may be able to join

Male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder.

Who cannot join

Clinically significant laboratory and/or ECG abnormalities
Pre-existing health conditions that would compromise patient safety
Mental retardation
Previous use of aripiprazole
Active psychosis

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Open Label Trial of Aripiprazole in the Treatment of CD in Adolescents

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.

Read the detailed description

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.

Conditions: Conduct Disorder
Being tested: Aripiprazole
Keywords: Aripiprazole
Medical subject headings: Conduct Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AripiprazoleDrug
Also called Abilify
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.

Study groups in NCT00250705
Study group	Role	What they receive
Adolescent Conduct Disorder Males	Other	All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole. Receives: Drug: Aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)
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.
Measured: 6 weeks
Overt Aggression Scale-Modified (OAS-M)
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.
Measured: 6 weeks
Children's Aggression Scale-Parent Version
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.
Measured: 6 weeks

Secondary outcomes (2)

Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).
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.
Measured: 6 weeks
Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).
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)
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 200423 Mar 2009

First posted8 Nov 2005 (estimated)
Study start17 Nov 2004
Primary completion23 Mar 2009
Study completion23 Mar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Conduct DisorderStudies of the same condition, open and under way.
More trials run by University of IowaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: open label trial
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00250705
Sponsor's protocol ID: 200306035
Status last verified: Jul 2017
First submitted: 4 Nov 2005
Last updated: 11 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 22073384

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Conduct Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Trial of Aripiprazole in the Treatment of CD in Adolescents
ClinicalTrials.gov ID: NCT00250705
Acronym / sponsor ID: 200306035
Conditions: Conduct Disorder
Keywords: Aripiprazole
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Collaborators: Bristol-Myers Squibb
Study start: 17 Nov 2004 (actual)
Primary completion: 23 Mar 2009 (actual)
Study completion: 23 Mar 2009 (actual)
First posted: 8 Nov 2005 (estimated)
Results: Posted 11 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: open label trial

Arm	Type	Receives
Adolescent Conduct Disorder Males	Other	Drug: AripiprazoleAll subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.

Who may qualify

Ages: 13 to 17 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder.

Key exclusion criteria (5 listed)

Clinically significant laboratory and/or ECG abnormalities
Pre-existing health conditions that would compromise patient safety
Mental retardation
Previous use of aripiprazole
Active psychosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AripiprazoleAlso: AbilifyThe 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.	Drug	Adolescent Conduct Disorder Males

Primary outcome

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.

2 secondary outcomes

Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).
Time frame: 6 weeks
Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).
Time frame: 6 weeks

Results and safety

Results posted to the registry on 11 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole Treatment of Conduct Disorde	12	10

Primary outcome: The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Aripiprazole Treatment of Conduct Disorder n = 10
Value	1.7 (0.8)

Population analysed: ITT

Primary outcome: Overt Aggression Scale-Modified (OAS-M)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Adolescent Conduct Disorder Males n = 10
verbal aggression	1.0 (1.2)
property aggression	0.6 (1.9)
self aggression	0.6 (1.9)
physical aggression	1.6 (3.9)

Population analysed: ITT

Primary outcome: Children's Aggression Scale-Parent Version

Time frame: 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Adolescent Conduct Disorder Males n = 10
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)

Population analysed: ITT

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were enrolled for a 6 week study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole in the Treatment of Conduct Disorder	0 of 10 (0%)	10 of 10 (100%)	0 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22073384Kuperman 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samuel Kuperman, M.D. principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aripiprazole in people with Conduct Disorder, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00250705, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.