Aripiprazole in Fragile X Syndrome

Fragile X Syndrome Clinical Trial

Official title:

Aripiprazole in Fragile X Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420459
• Other study ID #: 0609-22
• Secondary ID: FXS01
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2007
• Last updated: April 25, 2012
• Start date: April 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2012
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with FXS. We hypothesize that aripiprazole will be effective in decreasing aggression, SIB, agitation, and interfering repetitive behavior commonly observed in individuals with FXS. We also hypothesize that aripiprazole will be well tolerated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Males and females between the ages of 5 and 35 years and

2. Body weight greater than or equal to 15 kg

3. Confirmed diagnosis of Fragile X Syndrome based upon genetic testing results.

4. Outpatients.

5. Psychotropic medication-free for at least 2 weeks prior to screening laboratory tests and electrocardiogram. (Except 5 weeks for fluoxetine and 4 weeks for all typical and atypical antipsychotics that have been administered for at least a 4 week period.) Exceptions to medication-free status will include drugs given at bedtime targeting insomnia. Such drugs may include melatonin, clonidine, chloral hydrate, diphenhydramine, ramelteon, benzodiazepines, or other sedative-hypnotics.

6. Clinical Global Impression Scale Severity score (CGI-S) of at greater than or equal to 4 (Moderately Ill)

7. A score of at greater than or equal to 18 on the Irritability subscale of the Aberrant Behavior Checklist (ABC) at screen and baseline.

8. Mental age of greater than or equal to 18 months as measured by the Wechsler, revised Leiter, or Mullen tests

9. Each subject must be in good physical health as determined by screening procedures which will include a detailed medical history, complete physical and neurological examination.

Exclusion Criteria:

1. DSM-IV diagnosis of schizophrenia, another psychotic disorder, bipolar disorder or alcohol or other substance abuse within the last 6 months.

2. A significant medical condition such as heart, liver, renal or pulmonary disease, or an actively treated seizure disorder, as determined by history, physical examination or laboratory testing.

3. Subjects with an unstable seizure disorder will be excluded.

4. Females with a positive urine pregnancy test.

5. Evidence of a prior adequate trial of aripiprazole (defined as a duration of greater than or equal to 2 weeks at a dose of at least 5 mg per day). When there is not evidence of a prior adequate trial of aripiprazole, subjects must be medication-free for at least 2 weeks prior to baseline.

6. Evidence of hypersensitivity to aripiprazole (defined as an allergic response [e.g., skin rash] or potentially serious adverse effect [e.g., significant tachycardia]).

7. History of neuroleptic malignant syndrome.

8. Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study including being unable to comply with the requirements of the study for any reason.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavioral Problems Associated With Fragile X Syndrome
• Fragile X Syndrome
• Syndrome

Intervention

Drug:
• Aripiprazole
All subjects will initially receive 2.5 mg/day of aripiprazole during the first week. The dosage may be increased to a maximum of 20 mg/day over 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent-rated irritability subscale of Aberrant Behavior Checklist (ABC)		Completed at every visit	No
Primary	Clinician-rated Clinical Global Impression (CGI)- global improvement item (CGI-I)		Completed at every visit	No
Secondary	Aberrant Behavior Checklist sub-scales II, III, IV &V		Completed at every visit	No
Secondary	The Vineland Adaptive Behavior Scales		Screen Visit	No
Secondary	The Vineland Maladaptive Behavior Subscales		Every 4 weeks	No
Secondary	The Children's Yale-Brown Obsessive Compulsive Scale		At baseline and every 4 weeks.	No