Clinical trial NCT00299715 (phase 3, status: completed)
Conditions: bipolar disorder, mood disorders
ICD codes: F31.81, F31.89, F31.9, F25.0, F31.0, F31.31, F31.32, F34.81, F39, F34.9, F43.21, F10.14, F10.24, F11.14
Drugs: paliperidone extended-release
SMILES: CC1=C(CCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C(=O)N2CCCC(O)C2=N1
Eligibility criteria:

        Inclusion Criteria:

          -  Meets Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM IV)
             criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without
             psychotic features)

          -  history of at least 1 previously documented manic or mixed episode requiring medical
             treatment within 3 years before the screening phase

          -  total score of at least 20 on the Young Mania Rating Scale at screening and at
             baseline visit

          -  if taking mood stabilizers, antipsychotics, or antimanic drugs, must have discontinued
             that medication at least 3 days before baseline

          -  women must be postmenopausal (no spontaneous menses for at least 2 years), 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, intrauterine devices,
             double-barrier method, and male partner sterilization)

          -  able and willing to comply with self-administration of medication, or have consistent
             help or support available.

        Exclusion Criteria:

          -  Meets Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition criteria
             for any type of episode associated with Bipolar disorder other than Bipolar I
             Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features)

          -  meets DSM-IV criteria for rapid cycling and schizoaffective disorder

          -  known or suspected borderline or antisocial personality disorder

          -  in the opinion of the study doctor, is at significant risk for suicidal or violent
             behavior during the course of the study

          -  known or suspected history of substance dependence (excluding nicotine and caffeine)
             within the previous 3 months

          -  serious or unstable, medical illness (e.g., cardiovascular disease, neurologic,
             hematologic, renal, immunologic, metabolic, or other systemic illness), or has a
             history of uncontrolled or insulin-dependent diabetes mellitus

          -  history of severe, pre-existing gastrointestinal narrowing or inability to swallow
             study drug with the aid of water

          -  results at screening or baseline for liver function tests greater than twice the upper
             limit of the central laboratory reference range

          -  has active hypo- or hyperthyroidism unless stabilized on appropriate medication for at
             least 3 months before the screening phase

          -  history of neuroleptic malignant syndrome

          -  has a moderate-to-severe degree of tardive dyskinesia at screening

          -  known or suspected history of hypersensitivity or intolerance to paliperidone or
             risperidone or suspected history of life-threatening drug allergy or hypersensitivity
             to any drug

          -  has received benzodiazepines at doses equal to 4 mg/day of lorazepam or higher for a
             period of 3 months or longer immediately before the screening phase

          -  use of clozapine, aripiprazole, or fluoxetine within 1 month before the screening
             phase

          -  has received antidepressant therapy, other than fluozetine, within 7 days before the
             first dose of study drug

          -  use of antiparkinsonian drugs or beta-blockers (for any indication other than
             hypertension) within 3 days before the first dose of study drug

          -  have used cocaine, phencyclidine, amphetamine, methylphenidate, pemoline, an opioid
             (excluding codeine), hallucinogen, or any other drug that may be associated with manic
             symptoms as evidenced by a positive urine drug screen

          -  alcohol intoxication within 3 days before the first dose of study drug

          -  has had an injection of RISPERDAL CONSTA within 5 weeks before the screening phase, or
             has received another depot antipsychotic within 1 treatment cycle before the screening
             phase

          -  electroconvulsive therapy within 6 months before the first dose of study drug

          -  women who are pregnant or nursing

          -  has an anticipated life expectancy of 6 months or less.