IV Citalopram + TMS for Depression

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of California, Los Angeles

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.

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

I haven't taken any brain-affecting meds for 10 days, except fluoxetine which I stopped 5 weeks ago.

I am between 21 and 55 years old.

I have been diagnosed with major depression and scored over 17 on a depression scale.

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Exclusion Criteria

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.

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Participant Groups

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.

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