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Effects of Intravenous (IV) Citalopram Hydrochloride During Transcranial Magnetic Stimulation in Major Depressive Disorder (MDD)

NCT04846829 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Placebo

saline PBO will be administered intravenously using established clinical procedures. A single dose if saline PBO will be delivered intravenously under double-blind conditions via pump over a 40-minute period.

DEVICE

intermittent theta burst stimulation

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

DRUG

intravenous citalopram hydrochloride (CIT)

CIT will be administered intravenously using established clinical procedures. 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.

DEVICE

continuous theta burst stimulation

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2028-04-24
Completion
2028-04-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04846829 on ClinicalTrials.gov