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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

Must not have

History of ECT within the past six months, or history of failure to benefit from prior TMS treatment of MDD.

A history of prior treatment with IV CIT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 10 days

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had ECT in the last 6 months or TMS did not help my depression.

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I have been treated with IV CIT before.

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I am not pregnant, breastfeeding, and I use reliable birth control.

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I have a history of epilepsy, seizures, or severe head injury.

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I am currently taking medication that affects my brain function.

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I have had thoughts about harming myself.

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I have a history of brain conditions that could affect study results.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change in Hamilton Depression Scale

Secondary study objectives

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