Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)

University of Iowa

Status and phase: Completed; Phase 3

Conditions: Depression; Depressive Disorder

Treatments: Procedure: Repetitive transcranial magnetic stimulation (rTMS); Drug: Citalopram; Procedure: Sham rTMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00044798

R01MH063405 (U.S. NIH Grant/Contract)

DATR A4-GPX

Details and patient eligibility

About

This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of depression associated with small vascular lesions in the brain (vascular depression).

Full description

Vascular depression is a condition that typically affects the elderly and is associated with small vascular lesions. It is more resistant to treatment and has a poorer outcome than nonvascular depression. By altering excitability in the cortical area of the brain, rTMS may be an effective treatment neuropsychiatric conditions, particularly depression.

Participants in this study will be randomly assigned to 15 treatments of either rTMS or sham rTMS for 3 weeks. Following treatment, participants will receive citalopram for 9 weeks. Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy will be measured. Improvements in activities of daily living, quality of life, and cognitive function will also be also measured.

Enrollment: 132 estimated patients

Sex: All

Ages: 51 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• DSM-IV diagnosis of unipolar major or minor depressive disorder
• Hamilton Depression Rating Scale score of at least 18
• Depression that is associated with cerebrovascular disease
• Failed at least 1 treatment for vascular depression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

132 participants in 2 patient groups

1

Experimental group

Description:

Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.

Treatment:

Drug: Citalopram

Procedure: Repetitive transcranial magnetic stimulation (rTMS)

2

Active Comparator group

Description:

Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.

Treatment:

Drug: Citalopram

Procedure: Sham rTMS