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Early Intervention With Fluoxetine in Autism

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00183339
First received: September 6, 2005
Last updated: February 7, 2014
Last verified: February 2014
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Autistic Disorder
Interventions: Drug: Fluoxetine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants who received placebo solution between .5ml and 5.0ml
Fluoxetine Participants who received liquid fluoxetine 2-20 mg (of 4mg/1ml solution) in AM using a flexible dose strategy and planned 36 week titration schedule

Participant Flow:   Overall Study
    Placebo     Fluoxetine  
STARTED     10     8  
COMPLETED     4     4  
NOT COMPLETED     6     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants will take the placebo
Fluoxetine Participants will take liquid fluoxetine 2-20 mg
Total Total of all reporting groups

Baseline Measures
    Placebo     Fluoxetine     Total  
Number of Participants  
[units: participants]
  10     8     18  
Age  
[units: participants]
     
<=18 years     10     8     18  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: months]
Mean ± Standard Deviation
  44.0  ± 6.6     42.6  ± 8.1     43.4  ± 7.4  
Gender  
[units: participants]
     
Female     0     0     0  
Male     10     8     18  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     2     3  
White     7     5     12  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     10     8     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Recruitment   [ Time Frame: 19 months ]

2.  Secondary:   Rate of Attrition   [ Time Frame: Measured at Month 12 ]

3.  Secondary:   Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire   [ Time Frame: 12 months ]

4.  Secondary:   Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
It took twice as long to recruit subjects for a study in children 30-58 months than it generally takes to recruit older children. It is possible to maintain subjects in double-blind trails for extended periods.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linmarie Sikich, MD
Organization: University of North Carolina
phone: 919 966 8653
e-mail: Lsikich@med.unc.edu


No publications provided


Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00183339     History of Changes
Other Study ID Numbers: U54 MH66418, U54MH066418
Study First Received: September 6, 2005
Results First Received: September 10, 2013
Last Updated: February 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board