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Selective Serotonin Reuptake Inhibitor
IV Citalopram + TMS for Depression
Phase < 1
Waitlist Available
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
21-55 years of age
MDD currently depressed subjects will meet DSM-V criteria for MDD based on the Mini-International Neuropsychiatric Interview (MINI) with a 17-item Hamilton Depression Rating Scale (HamD17) score > 17
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 10 days
Awards & highlights
Study Summary
This trial will study the effects of a medication and transcranial magnetic stimulation on people with Major Depressive Disorder.
Who is the study for?
This trial is for adults aged 21-55 with Major Depressive Disorder who haven't responded to at least two antidepressants and have a HamD17 score > 17. Participants must not have taken certain brain-affecting medications recently, except fluoxetine which requires a longer washout period. Those with unstable medical conditions, abnormal ECGs, or metal implants unsafe for MRI/TMS are excluded.Check my eligibility
What is being tested?
The study tests the effects of IV citalopram hydrochloride versus placebo when combined with theta burst stimulation (TBS), a type of transcranial magnetic stimulation (TMS), on individuals with MDD. Over four weeks, participants will receive one infusion treatment and ten TBS treatments alongside mood surveys and brain activity assessments.See study design
What are the potential side effects?
Potential side effects may include discomfort at the TMS site, headache, lightheadedness, seizures in very rare cases for those predisposed to them, and typical citalopram side effects like nausea, dry mouth, increased sweating or yawning.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 55 years old.
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I have been diagnosed with major depression and scored over 17 on a depression scale.
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I have tried at least two antidepressants without remission in my current episode.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 10 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 10 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent change in Hamilton Depression Scale
Secondary outcome measures
Mental Depression
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: intermittent Theta Burst StimulationExperimental Treatment1 Intervention
10 sessions of treatment with cTBS to right DLPFC
TBS consists of three TMS pulses given at 50 Hz, with this triplet repeated at a frequency of 5 Hz (every 200 ms).
iTBS paradigm of a 2 s train repeated every 10 seconds
Group II: continuous Theta Burst StimulationExperimental Treatment1 Intervention
10 sessions of treatment with iTBS to left or cTBS to right DLPFC
TBS consists of three TMS pulses given at 50 Hz, with this triplet repeated at a frequency of 5 Hz (every 200 ms).
1800 pulses of cTBS will be delivered
Group III: intravenous citalopram hydrochloride (CIT)Active Control1 Intervention
A single 40 mg dose of CIT diluted in 60 cc normal saline will be delivered intravenously under double-blind conditions via pump over a 40-minute period.
Group IV: Placebo infusionPlacebo Group1 Intervention
Placebo comparator to active study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intermittent theta burst stimulation
2020
Completed Phase 2
~220
continuous theta burst stimulation
2011
N/A
~130
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,821 Total Patients Enrolled
101 Trials studying Depression
48,413 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any brain-affecting meds for 10 days, except fluoxetine which I stopped 5 weeks ago.I haven't taken antidepressants, anticonvulsants, or similar medications in the last 30 days.I have had ECT in the last 6 months or TMS did not help my depression.I am not taking any medications from a specific list, except for topical corticosteroids.I have no major health issues found in physical exams or lab tests.My current medication does not affect brain function or interfere with the study.I have been treated with IV CIT before.I am not pregnant, breastfeeding, and I use reliable birth control.I am between 21 and 55 years old.I have a history of epilepsy, seizures, or severe head injury.You have another mental health condition like anxiety or psychosis, or your depression is caused by a medical condition or substance use.I am currently taking medication that affects my brain function.You are currently using illegal drugs.I have been diagnosed with major depression and scored over 17 on a depression scale.I have had thoughts about harming myself.I have a medical condition that affects my brain function or could be causing my depression.I have tried at least two antidepressants without remission in my current episode.I have a history of brain conditions that could affect study results.You have had an allergic reaction or could not tolerate citalopram in any form.
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to contribute to this research endeavor?
"This investigation seeks 30 individuals with depression aged between 21 and 55. To qualify, prospective participants must have already attempted to find remission through two antidepressant medications (Vasavada et al., 2016) in their current episode, abstain from any neural-altering drugs for at least ten days (except fluoxetine which requires a five-week washout), satisfy DSM-V criteria of Major Depressive Disorder as assessed by the Mini International Neuropsychiatric Interview and score higher than 17 on the Hamilton Depression Rating Scale (Hamilton 1960)."
Answered by AI
Is this trial actively seeking participants?
"Clinicaltrials.gov indicates that, as of the most recent update on May 17th 2022, this medical trial is not actively recruiting participants. Despite this inactivity, 1298 other clinical trials are still enrolling patients at present."
Answered by AI
Is the age qualification for this experiment restricted to those under 50 years old?
"As per the criteria for this research, applicants aged 21-55 are eligible to participate. There is a total of 193 trials available for those below 18 and 970 studies open to individuals older than 65 years old."
Answered by AI
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