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

NCT02221635 | Unknown DMC

• 2 other identifiers: Yunchun ChenXijing H
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizoaffective Disorder

Keywords

Schizoaffective Disorder; Repetitive transcranial magnetic stimulation (rTMS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Positive and Negative Syndrome Scale

  Up to 15 Months

• Clinical Global Impression of Severity for Schizoaffective Disorder

  Up to 15 Months

• Personal and Social Performance Scale

  Up to 15 Months

• Change in mood symptoms

  Up to 15 Months

Study Arms (2)

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

Risperidone

Risperidone (2-4mg) was took orally.

Drug: Risperidone

Interventions

rTMS + risperidone 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.

rTMS+Risperidone

Risperidone DRUG

Risperidone (2-4 mg) was took orally.

Risperidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead
• The No.3 hospital of PLA: collaborator
• The No.91 hospital of PLA: collaborator
• No. 102 Hospital of Chinese People's Liberation Army: collaborator

Study Sites (1)

Qingrong

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Transcranial Magnetic Stimulation; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tan QingRong, MD

  XiJing Hospital, Xi'An, Shanxi, China

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2012
• First Posted: August 20, 2014
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

CN (1)