Trial record 1 of 47 for:    "Fragile X syndrome"
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Aripiprazole in Fragile X Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00420459
First received: January 9, 2007
Last updated: April 25, 2012
Last verified: April 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole in Fragile X Syndrome

Resource links provided by NLM:


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 ]

Enrollment: 12
Study Start Date: April 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (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.
    Other Name: Abilify
  Eligibility

Ages Eligible for Study:   5 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00420459

Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Christopher J McDougle, MD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00420459     History of Changes
Other Study ID Numbers: 0609-22, FXS01
Study First Received: January 9, 2007
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fragile X Syndrome
Syndrome
Chromosome Disorders
Congenital Abnormalities
Disease
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Intellectual Disability
Mental Retardation, X-Linked
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Sex Chromosome Disorders
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014