Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.

NCT00397033 | Completed Phase 3 Results

• 2 other identifiers: CR010498R076477SCA3001
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to measure the effectiveness and assess the safety of two dosages of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

Conditions

Schizoaffective Disorder; Psychotic Disorder

Keywords

Schizoaffective Disorder; antipsychotic; paliperidone; placebo

Outcome Measures

Primary Outcomes (2)

• Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score

  The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

  Baseline

• The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.

  The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

  Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point

Secondary Outcomes (12)

• Number of Participants With Response

  Baseline to Week 6 LOCF End Point

• Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score

  Baseline to Week 6 LOCF End Point

• Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score

  Baseline to Week 6 LOCF End Point

• Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score

  Baseline to Week 6 LOCF End Point

• Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score

  Baseline to Week 6 LOCF End Point

Other Outcomes (4)

• Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16

  Baseline

• Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16

  Baseline to Week 6 LOCF End Point

• Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16

  Baseline

Study Arms (3)

002

EXPERIMENTAL

Paliperidone ER 12mg/day paliperidone er for 6 weeks

Drug: Paliperidone ER

001

EXPERIMENTAL

Paliperidone ER 6mg/day paliperidone er for 6 weeks

Drug: Paliperidone ER

003

PLACEBO COMPARATOR

Placebo Placebo for 6 weeks

Drug: Placebo

Interventions

Paliperidone ER DRUG

6mg/day paliperidone er for 6 weeks

001

Placebo DRUG

Placebo for 6 weeks

003

Eligibility Criteria

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

You may qualify if:

• Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder
• A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of \>= 60
• A score of \>= 16 on Young Mania Rating Scale (YMRS) or a score of \>= 16 on the Hamilton Depression Rating Scale (HAM-D 21)

You may not qualify if:

• A primary active mental illness diagnosis other than schizoaffective disorder
• Patients with first episode psychosis
• Active substance dependence within previous 6 months
• Treatment with clozapine within 6 months of randomization
• A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication
• Pregnancy, breast-feeding, or planning to become pregnant

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Janssen, LP: collaborator

Related Publications (2)

• Alphs L, Fu DJ, Turkoz I. Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother. 2016;17(6):871-83. doi: 10.1517/14656566.2016.1161029. Epub 2016 Mar 24.

  PMID: 26934062 DERIVED

• Canuso CM, Lindenmayer JP, Kosik-Gonzalez C, Turkoz I, Carothers J, Bossie CA, Schooler NR. A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. J Clin Psychiatry. 2010 May;71(5):587-98. doi: 10.4088/JCP.09m05564yel.

  PMID: 20492853 DERIVED

Related Links

• A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dosages of paliperidone ER in the treatment of patients with schizoaffective disorder

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Vice President, Medical Affairs, CNS
• Organization: Ortho McNeil Janssen Scientific Affairs, LLC

609-730-2136

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 8, 2006
• Study Start: November 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 29, 2013
• Results First Posted: July 28, 2009

Record last verified: 2013-07