Trial Outcomes & Findings for A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia (NCT NCT00168311)

Results Overview

Scale for Assessment of Negative Symptoms \[SANS\]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of \>50 is considered to be a moderate-severe intensity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

3 weeks

Results posted on

2012-05-14

Participant Flow

A total of 20 patients were randomly assigned. Patients were recruited from the outpatient department of two public area mental health services and by referral from a number of private psychiatrists between January 2003 and July 2007.

Participant milestones

Participant milestones
Measure	Active Treatment Bilateral high frequency (10Hz) rTMS	Sham Treatment Sham bilateral rTMS treatment
Overall Study STARTED	12	10
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=12 Participants Bilateral high frequency (10Hz) rTMS	Sham Treatment n=10 Participants Sham bilateral rTMS treatment	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Australia	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Scale for Assessment of Negative Symptoms \[SANS\]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of \>50 is considered to be a moderate-severe intensity.

Outcome measures

Outcome measures
Measure	Active Treatment n=12 Participants Bilateral high frequency (10Hz) rTMS	Sham Treatment n=8 Participants Sham bilateral rTMS treatment
Scale for the Asessment of Negative Symptoms (SANS)	38.8 Scores on a scale Standard Deviation 11.0	53.7 Scores on a scale Standard Deviation 8.3

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Paul Fitzgerald

Monash Alfred Psychiatry Research Centre

Phone: +61 3 9076 6564

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place