Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Schizoaffective
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|ClinicalTrials.gov Identifier: NCT02221635|
Recruitment Status : Unknown
Verified August 2014 by Xijing Hospital.
Recruitment status was: Recruiting
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
|Condition or disease||Intervention/treatment|
|Schizoaffective Disorder||Procedure: rTMS + risperidone Drug: Risperidone|
|Study Type :||Observational|
|Estimated Enrollment :||540 participants|
|Official Title:||A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||January 2015|
Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.At the same time,risperidone (2-4mg) was took orally.
Procedure: rTMS + risperidone
Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months. Meanwhile,risperidone (2-4 mg) was took orally.
Risperidone (2-4mg) was took orally.
Risperidone (2-4 mg) was took orally.
- Time for relapse [ Time Frame: Monthly during the 15 month double-blind Relapse Prevention Period. ]Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period.
- Positive and Negative Syndrome Scale [ Time Frame: Up to 15 Months ]Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores
- Clinical Global Impression of Severity for Schizoaffective Disorder [ Time Frame: Up to 15 Months ]Illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA)
- Personal and Social Performance Scale [ Time Frame: Up to 15 Months ]Change in subject functioning using the Personal and Social Performance Scale (PSP)
- Change in mood symptoms [ Time Frame: Up to 15 Months ]Change in mood symptoms as measured by YMRS (Young Mania Rating Scale,in subjects with YMRS=16 at enrollment) and HAM-D-21) (in subjects with HAM-D-21=16 at enrollment)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221635
|Xi'an, Shaanxi, China, 710032|
|Contact: Wang Hua Ning, Phd 8613609161341 email@example.com|
|Principal Investigator: Wang Hua ning, Phd|
|Study Chair:||Tan QingRong, MD||XiJing Hospital, Xi'An, Shanxi, China|