A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Flexible Dose Paliperidone ER in the Treatment of Subjects with Schizoaffective Disorder
- Conditions
- Schizoaffective disorderMedDRA version: 8.1Level: LLTClassification code 10039621Term: Schizoaffective disorder
- Registration Number
- EUCTR2006-005734-20-BG
- Lead Sponsor
- Janssen L.P.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1.The subject must be, in the opinion of the investigator, able to understand the informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), as appropriate. All subjects must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. In addition, reasonable efforts should be made to provide information about the study to a subject’s designated contact person. Note: It is acceptable to have additional signatures if required by local regulations. In addition, where permitted, if a subject has an appointed legal representative, both the representative and the subject will sign the form. Subjects who are unable to provide their own consent or who have been involuntarily committed to psychiatric hospitalization are not eligible to enroll in the study
2.Subjects may be male or female.
3.Age must be between 18 and 65 years, inclusive
4.Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patch, and male partner sterilization). Female subjects must also have a negative urine pregnancy test at screening and baseline (Day 0).
5.Subjects must have lifetime and current diagnosis of schizoaffective disorder (DSM-IV 295.70), as confirmed by the SCID at screening
6.Subjects must be experiencing an acute exacerbation, with a PANSS total score greater than or equal to 60 at the time of study enrollment and at time of randomization
7.The onset of current episode (exacerbation of symptoms) must be no less than 4 days and no more than 4 weeks prior to screening
8.At screening and at randomization, subjects must have a score of ?4 on at least 2 of the following PANSS items: Hostility (P7), Excitement (P4), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
9.At screening and at randomization, subject must have a score of >=16 on YMRS OR a score of greater than or equal to 16 on the HAM-D 21
10.Subjects must be hospitalized or be willing to be hospitalized at the time of screening
11.Subjects must be healthy on the basis of physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
12.Subjects must be able, in the opinion of the investigator, to be compliant with self-administration of medication or have consistent help/support available.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Women who are pregnant (as confirmed by urine pregnancy test performed at screening and baseline), planning to become pregnant, or breast-feeding
2.Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
3.Subjects with a urine drug screen that is positive for cocaine, opiates, PCP or amphetamines at screening or baseline
4.Subjects with an inability to swallow the study medication whole with the aid of water (subjects must not chew, divide, dissolve, or crush the study medication, as this may affect the release profile)
b. Psychiatric history
5.Subjects meeting the DSM-IV criteria for major depressive disorder (diagnostic categories 296.2x and 296.3x), bipolar disorder (diagnostic categories 296.0x, 296.40, 296.4x, 296.5x, 296.6x, 296.7, and 296.89), or schizophrenia (diagnostic categories 295.10, 295.20, 295.30, 295.60, and295.90),or schizophreniform disorder
(diagnostic category 295.40).
6.Subjects currently meeting criteria for any other Axis I diagnosis except substance abuse
7.Subjects meeting the DSM-IV criteria for substance dependence in the 6 months before study entry
8.Subjects with an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder
9.Subjects who have attempted suicide within 12 months before study entry or are at imminent risk of suicide according to the investigator’s clinical judgment
10.First-episode subjects (no prior history of psychotic symptoms)
c. Treatment history
11.Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <4 weeks prior to screening
12.Subjects with a history of receiving electroconvulsive therapy in the 6 months before study entry
13.Subjects with a history of hypersensitivity to paliperidone or risperidone or any of their excipients
14.Subjects who have participated in a clinical investigation or received an experimental therapy within 30 days before study entry or have participated in >2 clinical studies within the last 12 months
15.Subjects receiving depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 2 treatment cycles of screening visit
16.Subjects with a history of neuroleptic malignant syndrome
17.Subjects with a previous history of lack of response to antipsychotic medication. Lack of response is defined as the subject having had (at least twice) a documented medical history of no clinical response, despite adequate doses and durations of treatment, or the inability to tolerate effective doses.
18.Subjects receiving therapy with clozapine or having received therapy with clozapine within 3 months prior to randomization
19.Subjects receiving therapy with carbamazepine and monoamine oxidase inhibitors
d. Somatic history
20.Subjects with a serious neurological disease, including but not limited to Alzheimer’s disease, vascular dementia, Parkinson’s disease, unstable seizure disorder, intracranial lesions, hydrocephalus, or significant head trauma
21.Relevant history of or current presence of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine (including untreated or unstable hypo/hyperthyroidism unless stabilized on an appropriate medication for
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method