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

• Status: Unknown status
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead 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
• Treatments: Risperidone

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