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

Schizoaffective Disorder Clinical Trial

Official title:

A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02221635
• Other study ID #: Yunchun Chen
• Secondary ID: Xijing H
• Status: Recruiting
• Phase: Phase 3
• First received: August 19, 2012
• Last updated: August 18, 2014
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: August 2014
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder

Intervention

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.

Drug:
• Risperidone
Risperidone (2-4 mg) was took orally.

Locations

Country	Name	City	State
China	Qingrong	Xi'an	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
Xijing Hospital	No. 102 Hospital of Chinese People's Liberation Army, The No.3 hospital of PLA, The No.91 hospital of PLA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for relapse	Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period.	Monthly during the 15 month double-blind Relapse Prevention Period.	No
Secondary	Positive and Negative Syndrome Scale	Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores	Up to 15 Months	No
Secondary	Clinical Global Impression of Severity for Schizoaffective Disorder	Illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA)	Up to 15 Months	No
Secondary	Personal and Social Performance Scale	Change in subject functioning using the Personal and Social Performance Scale (PSP)	Up to 15 Months	No
Secondary	Change in mood symptoms	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)	Up to 15 Months	No