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

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

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).

Study Overview

• Status: Unknown
• Conditions: Schizoaffective Disorder
• Intervention / Treatment: Procedure: rTMS + risperidone; Drug: Risperidone

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.

• Study Type: Observational
• Enrollment (Anticipated): 540

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Qingrong
      • Contact: Wang Hua Ning, Phd; Phone Number: 8613609161341; Email: xskzhu@fmmu.edu.cn
      • Principal Investigator: Wang Hua ning, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Ages Eligible for Study: 18 Years to 65 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; Risperidone (2-4mg) was took orally.	Drug: Risperidone; Risperidone (2-4 mg) was took orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Personal and Social Performance Scale	Change in subject functioning using the Personal and Social Performance Scale (PSP)	Up to 15 Months
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: No. 102 Hospital of Chinese People's Liberation Army; The No.3 hospital of PLA; The No.91 hospital of PLA
• Investigators: Study Chair: Tan QingRong, MD, XiJing Hospital, Xi'An, Shanxi, China

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): January 1, 2015

Study Registration Dates

• First Submitted: August 19, 2012
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (ESTIMATE): August 20, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Schizoaffective Disorder; Repetitive transcranial magnetic stimulation (rTMS)
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: Yunchun Chen; Xijing H (XijingH)