IV Citalopram + TMS for Depression
Trial Summary
What is the purpose of this trial?
This study will recruit 30 subjects diagnosed with Major Depressive Disorder (MDD). Subjects will be recieve one infusion treatment of citalopram or placebo and 10 treatments of a form of transcranial magnetic stimulation, theta burst stimulation (TBS). Subjects will also undergo brain scans, quantitative electroencephalography (qEEG) brain activity recordings, and mood surveys. Study activities will be performed over the course of 4 weeks.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications that significantly affect brain function at least ten days before joining the trial, except for fluoxetine, which requires a five-week break. This includes antidepressants, anticonvulsants, and other similar medications.
What data supports the effectiveness of the drug citalopram for depression?
Research shows that citalopram, when used as an additional treatment for patients who don't fully respond to other depression medications, can significantly improve symptoms compared to a placebo. A meta-analysis also found that citalopram is more effective than a placebo in reducing symptoms of major depressive disorder.12345
Is IV Citalopram + TMS safe for humans?
The safety of intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS), has been evaluated in several studies for depression, showing it to be generally safe and well-tolerated in humans. No adverse events were observed in a study on bipolar depression, and it has a similar safety profile to other TMS methods for treatment-resistant depression.678910
How is the treatment of IV Citalopram + TMS for depression different from other treatments?
This treatment combines IV Citalopram, a medication for depression, with Intermittent Theta Burst Stimulation (iTBS), a newer form of brain stimulation that is faster and requires less intensity than traditional methods. This combination may offer a unique approach by potentially enhancing the effects of both components for those with treatment-resistant depression.6791112
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single infusion of citalopram or placebo and 10 sessions of theta burst stimulation over two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Citalopram Hydrochloride
- Intermittent Theta Burst Stimulation
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor