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Early Intervention With Fluoxetine in Autism

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill Identifier:
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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
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 

  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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 10   8   18 
[Units: Participants]
<=18 years   10   8   18 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Months]
Mean (Standard Deviation)
 44.0  (6.6)   42.6  (8.1)   43.4  (7.4) 
[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
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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

Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill Identifier: NCT00183339     History of Changes
Other Study ID Numbers: U54MH066418 ( US NIH Grant/Contract Award Number )
Study First Received: September 6, 2005
Results First Received: September 10, 2013
Last Updated: February 7, 2014