Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders

University of North Carolina (UNC)

Status and phase: Completed; Phase 1

Conditions: Autism Spectrum Disorders

Treatments: Drug: Placebo; Drug: Citalopram

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00609531

The Dana Foundation

K23MH081285 (U.S. NIH Grant/Contract)

NIH/NCRR K12 RR023248

04-0975

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 10 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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]

Exclusion criteria

• 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)
• 4. 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]

Trial design

12 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Individuals with an Autism Spectrum Disorder receiving citalopram

Treatment:

Drug: Citalopram

Placebo

Placebo Comparator group

Description:

Individuals with an Autistic Spectrum Disorder receiving placebo

Treatment:

Drug: Placebo