Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Aripiprazole in Fragile X Syndrome
This study is currently recruiting participants.
Verified by Indiana University, July 2008
Sponsored by: Indiana University School of Medicine
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00420459
  Purpose

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.


Condition Intervention Phase
Fragile X Syndrome
Behavioral Problems Associated With Fragile X Syndrome
Drug: Aripiprazole
Phase II

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies fragile X syndrome L1 syndrome
MedlinePlus related topics: Fragile X Syndrome
Drug Information available for: Aripiprazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title: Aripiprazole in Fragile X Syndrome

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Parent-rated irritability subscale of Aberrant Behavior Checklist (ABC) [ Time Frame: Completed at every visit ] [ Designated as safety issue: No ]
  • Clinician-rated Clinical Global Impression (CGI)- global improvement item (CGI-I) [ Time Frame: Completed at every visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aberrant Behavior Checklist sub-scales II, III, IV &V [ Time Frame: Completed at every visit ] [ Designated as safety issue: No ]
  • The Vineland Adaptive Behavior Scales [ Time Frame: Screen Visit ] [ Designated as safety issue: No ]
  • The Vineland Maladaptive Behavior Subscales [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • The Children's Yale-Brown Obsessive Compulsive Scale [ Time Frame: At baseline and every 4 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   6 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females between the ages of 6 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 Lieter, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420459

Contacts
Contact: Arlene E Kohn, BA 317-274-1990 aekohn@iupui.edu
Contact: Marianna Zaphiriou, BA 317-278-6253 mzaphiri@iupui.edu

Locations
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Christopher J McDougle, MD            
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Christopher J McDougle, MD Indiana University
  More Information

Responsible Party: Indiana University School of Medicine ( Christopher J. McDougle, M.D. )
Study ID Numbers: FXS01
Study First Received: January 9, 2007
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00420459  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Chromosomal abnormalities
X-linked mental retardation and macro-orchidism
Chromosome Disorders
Fragile X Syndrome
Mental Retardation
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Fragile X syndrome
Genetic Diseases, X-Linked
Neurologic Manifestations
Aripiprazole
Congenital Abnormalities
Neurobehavioral Manifestations

Additional relevant MeSH terms:
Disease
Tranquilizing Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Sex Chromosome Disorders
Mental Retardation, X-Linked
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009