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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
The No.3 hospital of PLA
The No.91 hospital of PLA
No. 102 Hospital of Chinese People's Liberation Army
Information provided by (Responsible Party):
Xijing Hospital

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).

Condition or disease Intervention/treatment
Schizoaffective Disorder 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.

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Study Type : Observational
Estimated Enrollment : 540 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Personal and Social Performance Scale [ Time Frame: Up to 15 Months ]
    Change in subject functioning using the Personal and Social Performance Scale (PSP)

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ages Eligible for Study: 18 Years to 65 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
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

Information from the National Library of Medicine

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


Locations
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China, Shaanxi
Qingrong Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Wang Hua Ning, Phd    8613609161341    xskzhu@fmmu.edu.cn   
Principal Investigator: Wang Hua ning, Phd         
Sponsors and Collaborators
Xijing Hospital
The No.3 hospital of PLA
The No.91 hospital of PLA
No. 102 Hospital of Chinese People's Liberation Army
Investigators
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Study Chair: Tan QingRong, MD XiJing Hospital, Xi'An, Shanxi, China
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02221635    
Other Study ID Numbers: Yunchun Chen
Xijing H ( Registry Identifier: XijingH )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Xijing Hospital:
Schizoaffective Disorder
Repetitive transcranial magnetic stimulation (rTMS)
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents