Aripiprazole in Fragile X Syndrome
Information source: Indiana University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fragile X Syndrome; Behavioral Problems Associated With Fragile X Syndrome
Intervention: Aripiprazole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Indiana University School of Medicine Official(s) and/or principal investigator(s): Christopher J McDougle, MD, Principal Investigator, Affiliation: Indiana University
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.
Clinical Details
Official title: Aripiprazole in Fragile X Syndrome
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Parent-rated irritability subscale of Aberrant Behavior Checklist (ABC)Clinician-rated Clinical Global Impression (CGI)- global improvement item (CGI-I)
Secondary outcome: Aberrant Behavior Checklist sub-scales II, III, IV &VThe Vineland Adaptive Behavior Scales The Vineland Maladaptive Behavior Subscales The Children's Yale-Brown Obsessive Compulsive Scale
Eligibility
Minimum age: 5 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: April 2007
Last updated: April 25, 2012
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