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NCT00250705 · ClinicalTrials.gov registry record · Phase 4

Trial of Aripiprazole in the Treatment of CD in Adolescents

A Phase 4 study, sponsored by University of Iowa.

Completed
Registry status
Phase 4
Development phase
12
Enrollment target

NCT00250705: Completed Phase 4 study, sponsored by University of Iowa.

NCT00250705 is a Phase 4 study that has completed, run by University of Iowa. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00250705, a Phase 4 study, has completed, sponsored by University of Iowa.

COMPLETED
Registry status
Phase 4
Development phase
12 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2004-11-17
Est. Completion 2009-03-23
Phase Phase 4
University of Iowa

228 total trials

What the finished NCT00250705 record still lists

NCT00250705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.

NCT00250705 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00250705 about?

NCT00250705 is a clinical study titled "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 = ...

What is the current status of trial NCT00250705?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2004-11-17. Estimated completion is 2009-03-23.

What interventions are being tested in trial NCT00250705?

The interventions under investigation include: Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT00250705?

This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00250705's enrollment target sits among peer trials

12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00250705, the US trial registry maintained by the National Library of Medicine. NCT00250705 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.