NCT00609531

Brief Summary

The purpose of this proof of concept study is to use functional magnetic resonance imaging and behavioral assessments to investigate the effect of citalopram on restricted repetitive behaviors in people with autism spectrum disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

2.6 years

First QC Date

January 24, 2008

Last Update Submit

October 5, 2012

Conditions

Autism Spectrum Disorders

Keywords

Restricted repetitive behaviorsrestricted interestsAspergersAutism

Outcome Measures

Primary Outcomes (2)

  • Functional Magnetic Resonance Imaging

    two 2-hr scans

  • Clinicians Global Improvement Scale

    Upon study completion

Secondary Outcomes (1)

  • Childrens Yale-Brown Obsessive Compulsive Scale

    Baseline, wks 2, 4, 8, endpoint

Study Arms (2)

Active

EXPERIMENTAL

Individuals with an Autism Spectrum Disorder receiving citalopram

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Individuals with an Autistic Spectrum Disorder receiving placebo

Drug: Placebo

Interventions

CitalopramDRUG

Pill, 5-20mg once a day for twelve weeks

Also known as: Celexa
Active
PlaceboDRUG

Placebo pill once a day for twelve weeks

Placebo

Eligibility Criteria

Age10 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ambulatory status (outpatient) at time of consent
  • Age 10-55 years
  • Clinical diagnosis of Autism Spectrum Disorder
  • IQ greater than or equal to 70
  • Score greater than 8 on Children's Yale-Brown Obsessive Compulsive Scale
  • Free of psychoactive medication for at least: one month for fluoxetine; two weeks for other SSRIs and neuroleptics; and five days for stimulants prior to MRI scanning \[excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder\]

You may not qualify if:

  • Age less than 10 years or greater than 55 years, at time of consent
  • Estimated IQ \< 70
  • Uncontrolled epilepsy (seizure within 6 months prior to consent)
  • \. Presence of medical conditions that might interfere with participation, or where participation would be contraindicated
  • History of neurological injury: head trauma, poorly-controlled seizure disorder (seizure within the preceding six months), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview
  • History of claustrophobia
  • Implanted or irremovable metal in the body (including certain tattoos and permanent make-up)
  • Current pregnancy (as verified by testing prior to both initial dose administration of citalopram or placebo and prior to magnetic resonance imaging) due to the risk that may be associated with SSRI treatment and magnetic resonance imaging on fetal health
  • Medical contraindications to SSRI therapy as determined by history (including induction of mania or hypomania during SSRI therapy, or known drug allergy)
  • Concomitant medication that would interfere with study participation
  • Prior history of citalopram treatment failure at appropriate doses and duration
  • Prior history of treatment failure to two previous SSRI trials at appropriate doses and duration
  • Ongoing need for psychoactive medication other than study medication \[excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder, or diphenhydramine (Benadryl®)for sleep\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27759, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gabriel S Dichter, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

January 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 8, 2012

Record last verified: 2012-10

Locations

US(1)