Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Schizoaffective

NCT ID: NCT02221635

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 540 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-01-31

Brief Summary

The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of schizoaffective disorder. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores; Illness severity change as measured by Clinical Global Impression of Severity for depression (CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale; Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ).

Detailed Description

Schizoaffective disorder is a chronic illness and generally requires life-long treatment. To date however, no physical therapy has been evaluated in the maintenance treatment of schizoaffective disorder. This is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), medication-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation(rTMS), as monotherapy or as an adjunct to antipsychotic, relative to antipsychotic drugs in delaying the time to relapse in patients with schizoaffective disorder. Patients with acute symptoms of schizoaffective disorder will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose stabilization period, and a 12 months double-blind relapse prevention period. Patients without previous exposure to rTMS will be given 4 to 6 days of rTMS for tolerability testing. Patients can continue their current antipsychotic drugs through Day-1 (the day before the start of the study period). During the open-label periods, all patients will be treated with Risperidone. Patients who meet pre-determined stabilization criteria will be eligible to enter the double-blind relapse prevention period and will be randomly assigned to either receive rTMS or rTMS+Risperidone treatment. Efficacy will be evaluated during the study using a relapse assessment(time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period). Secondary Outcome Measures:Secondary Outcome Measures: Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores; Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale; Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ). Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements (temperature, pulse, and blood pressure), and weight. A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study.

Conditions

Schizoaffective Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.At the same time,risperidone (2-4mg) was took orally.

rTMS + risperidone

Intervention Type: PROCEDURE

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

Risperidone (2-4mg) was took orally.

Risperidone

Intervention Type: DRUG

Risperidone (2-4 mg) was took orally.

Interventions

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.

Intervention Type: PROCEDURE

Risperidone

Risperidone (2-4 mg) was took orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-IV)diagnosis of schizoaffective disorder
• Experiencing an acute exacerbation of psychotic symptoms
• A score of >=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
• A score of >=16 on YMRS and/or a score of >=16 on the HAM-D-21
• Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements

Exclusion Criteria

• A primary active mental illness diagnosis other than schizoaffective disorder
• Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior
• Subjects with first episode of psychosis
• Received electroconvulsive therapy in the past 3 months
• History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)
• Received long-acting antipsychotic medication within 2 injection cycles
• Received therapy with clozapine within 3 months
• A history of neuroleptic malignant syndrome
• Previous history of lack of response to antipsychotic medication
• Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening
• Receiving therapy with carbamazepine
• Receiving therapy with monoamine oxidase inhibitors
• Pregnant, breast-feeding, or planning to become pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The No.3 hospital of PLA

UNKNOWN

Sponsor Role: collaborator

The No.91 hospital of PLA

UNKNOWN

Sponsor Role: collaborator

No. 102 Hospital of Chinese People's Liberation Army

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tan QingRong, MD

Role: STUDY_CHAIR

XiJing Hospital, Xi'An, Shanxi, China

Locations

Qingrong

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wang Hua Ning, Phd

Role: primary

xskzhu@fmmu.edu.cn

8613609161341

Other Identifiers

Xijing H

Identifier Type: REGISTRY

Identifier Source: secondary_id

Yunchun Chen

Identifier Type: -

Identifier Source: org_study_id