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OpenTrials
Completed

NCT Number: NCT00186758

Transcranial Magnetic Stimulation in Bipolar Depression

To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)

to determine if non-responders can become responders if treated on the other side of the hemisphere

(rTMS)

Completed

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Key information

Conditions

Bipolar Affective Disorder Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street

Hamilton, Ontario, L8N 3K7, Canada

About this study

Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bipolar Depression
  • no physical health problems

Exclusion criteria

  • Metal in head/neck or skull
  • History of Epilepsy
  • Pregnancy
  • Pacemaker

Treatment and study plan

Transcranial Magnetic Stimulation (TMS)

Device

Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.

Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -

Other names: HamD, BDI II, VAS

Primary outcomes

  1. To compare antidepressant efficacy of right, left to sham

    Time frame: within 9 weeks

Secondary outcomes

  1. To determine if QEEG activity correlates with antidepressant response to rTMS

    Time frame: within 9 weeks

  2. To determine if non-responders can become responders if treating the opposite hemisphere

    Time frame: within 9 weeks

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Queen's University, Kingston, Ontario

Registry information

Official study title

A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression

Acronym: TMS

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2005
Registry last updated
Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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