Autism Spectrum DisordersPhase 1NCT00609531
Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
A Phase 1 study testing Citalopram in people with Autism Spectrum Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 55 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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]
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Citalopram, Placebo
- Keywords
- Restricted repetitive behaviors, restricted interests, Aspergers, Autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Also called Celexa
Pill, 5-20mg once a day for twelve weeks
PlaceboDrug
Placebo pill once a day for twelve weeks
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Individuals with an Autism Spectrum Disorder receiving citalopram Receives: Drug: Citalopram |
| Placebo | Placebo comparator | Individuals with an Autistic Spectrum Disorder receiving placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance Imaging
Measured: two 2-hr scans
Clinicians Global Improvement Scale
Measured: Upon study completion
Secondary outcomes (1)
Childrens Yale-Brown Obsessive Compulsive Scale
Measured: Baseline, wks 2, 4, 8, endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Gabriel Dichter, University of North Carolina, Chapel Hill
- Investigators
- Gabriel S Dichter, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609531
- Sponsor's protocol ID
- 04-0975
- Other IDs
- NIH/NCRR K12 RR023248, The Dana Foundation, K23MH081285
- Status last verified
- Oct 2012
- First submitted
- 24 Jan 2008
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00609531
- Acronym / sponsor ID
- 04-0975
- Conditions
- Autism Spectrum Disorders
- Keywords
- Restricted repetitive behaviors, restricted interests, Aspergers, Autism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: CitalopramIndividuals with an Autism Spectrum Disorder receiving citalopram |
| Placebo | Placebo comparator | Drug: PlaceboIndividuals with an Autistic Spectrum Disorder receiving placebo |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramAlso: CelexaPill, 5-20mg once a day for twelve weeks | Drug | Active |
| PlaceboPlacebo pill once a day for twelve weeks | Drug | Placebo |
Primary outcome
Functional Magnetic Resonance Imaging
Time frame: two 2-hr scans
Clinicians Global Improvement Scale
Time frame: Upon study completion
1 secondary outcome
Childrens Yale-Brown Obsessive Compulsive Scale
Time frame: Baseline, wks 2, 4, 8, endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel S Dichter, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Citalopram in people with Autism Spectrum Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Magnetic Resonance Imaging (time frame: two 2-hr scans). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2012.