NCT00186758

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 3, 2011

Status Verified

August 1, 2011

Enrollment Period

9 years

First QC Date

September 13, 2005

Last Update Submit

August 2, 2011

Conditions

Bipolar Affective Disorder

Keywords

Transcranial Magnetic StimulationTMS

Outcome Measures

Primary Outcomes (1)

  • To compare antidepressant efficacy of right, left to sham

    within 9 weeks

Secondary Outcomes (2)

  • To determine if QEEG activity correlates with antidepressant response to rTMS

    within 9 weeks

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

    within 9 weeks

Study Arms (2)

1, Phase l, True or Sham

SHAM COMPARATOR

this treatment will be True or Sham (placebo) on one side of the head, phase I

Device: Transcranial Magnetic Stimulation (TMS)

2, phase ll, Sham or True

ACTIVE COMPARATOR

This treatment will be Sham(placebo)or True on the other side of the head phase II.

Device: Transcranial Magnetic Stimulation (TMS)

Interventions

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 -

Also known as: HamD, BDI II, VAS
1, Phase l, True or Sham2, phase ll, Sham or True

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bipolar Depression
  • no physical health problems

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamilton, Ontario, L8N 3K7, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Gary Hasey, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

July 1, 2002

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 3, 2011

Record last verified: 2011-08

Locations

CA(1)