Answer > 0 on suicidality question of Patient Health Questionnaire (PHQ-9) Depression Scale
Poorly controlled depressive symptoms, defined as a baseline score of 10 or higher on the Patient Health Questionnaire (PHQ)-9 screening tool
3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale
> 0 in PHQ-9 question 9
Patients with the following mood disorders as judged by the investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM- IV]) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* Meets the cut-off score of >= 12 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD)-7 mood scale, respectively, or selects a positive response of \1, 2, or 3\ to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Patients has any of the following mood disorders as judged by the Investigator or a Psychiatrist, or who meets the cut-off score of >= 10 on the Patient Health Questionnaire (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of ‘1, 2, or 3’ to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\nNote: The psychiatric judgment overrules the mood assessment questionnaire result/investigators judgment
For participants on the BKM120 cohort only: \r\n* Any patient with a history of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, a history of suicide attempt or ideation, or homicide/homicidal ideation as judged by the investigator and/or based on recent psychiatric assessment will not qualify for study participation\r\n* >= CTCAE grade 3 anxiety at the time of study entry regardless of whether the anxiety is being treated with medications\r\n* Patients with the following mood disorders as judged by the investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n** Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n** >= CTCAE grade 3 anxiety\r\n** Meets the cut-off score of >= 10 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD)-7 mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Patient has a score >= 12 on the Patient Health Questionnaire (PHQ)-9 questionnaire
Patient selects a response of “1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)
Patients has any of the following mood disorders as judged by the Investigator or a psychiatrist, or who meets the cut-off score of >= the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7 (GAD-7) mood scale, respectively, or selects a positive response of ‘1, 2, or 3’ to questions number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* Note: the psychiatric judgment overrules the mood assessment questionnaire result or the investigators judgment
Patient has a score of >= 12 on the Patient Health Questionnaire (PHQ)-9 questionnaire, selects a response of “1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9), score >= 15 on Generalized Anxiety Disorder (GAD)-7 mood scale
Patient has a score >= 12 on the Patient Health Questionnaire (PHQ)-9 questionnaire
Patient selects a response of \1, 2 or 3\ to question number 9 on the PHQ-9-questionaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)
Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual [DSM]-IV) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety \r\n* Meets the cut-off score of >= 12 in the Patient Health Questionnaire 9-item (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Patients with active moderate or severe major mood or psychiatric disorder as judged by the investigator, primary care physician, counselor, psychiatrist, or as a result of the patient‘s mood assessment questionnaire that may interfere with the ability to comply with the trial; in addition, given the prior mood-associated toxicities, patients with a history of psychiatric hospitalization within the past 5 years, electroconvulsive therapy (ECT) within the past 5 years, or whose psychiatric condition has been unstable within 2 months prior to study enrollment requiring addition or change of psychotropic medications are not eligible; examples include, but are not limited to:\r\n* Medically documented history of or active major depressive episode requiring inpatient or intensive outpatient therapy, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or active ideation, or homicidal ideation (immediate risk of doing harm to others); patients under the care of a primary care physician who are treated with one oral agent and who have not required dose adjustments or new medications within 2 months prior to study enrollment and who otherwise meet eligibility requirements may be enrolled\r\n* >= Common Terminology for Adverse Events (CTCAE) version 4.0 grade 3 anxiety\r\n* Patients meeting the cutoff score of >= 12 in the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder-7 (GAD-7) mood scale, respectively, or who select a positive response of \1, 2, or 3\ to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) are not eligible
Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire (treating physician to decide on whether to administer questionnaire):\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v4) grade 3 anxiety\r\n* Meets the cut-off score of >= 10 in the Patient Health Questionnaire 9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7 (GAD-7) mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
For Arms A, C or D, patients with the following mood disorders as judged by the investigator or a psychiatrist, or as result of patient’s mood assessment questionnaire:\r\n* Medically documented history of major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV); NOTE: for patients with psychotropic treatments ongoing at baseline, the dose and schedule should not be modified within the previous 6 weeks prior to D1 of treatment with BKM120\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety \r\n* At screening, meets the cut-off score of >= 10 in the Patient Health Questionnaire (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD-7) mood scale, respectively, or selects a positive response of 1, 2 or 3 to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) will be excluded from the study unless overruled by the psychiatric assessment\r\n* Note: The psychiatric judgment overrules the mood assessment questionnaire result/investigator's judgment
Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* Meets the cut-off score of >= 12 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Patients have any of the following mood disorders as judged by the Investigator or a Psychiatrist, or who meets the cut-off score of ? 12 the PHQ-9 or a cut-off of ? 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) see Appendix 4.
Following mood disorders as judged by the investigator and/or symptom management service co-investigator, or as a result of patient’s mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* Current >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* Meets the cut-off score of >= 10 in the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) will be excluded from the study
Patient has a score ? 12 on the PHQ-9 questionnaire.
Patient has any of the following baseline mood disorders (not attributable to GBM) as judged by the Investigator or a Psychiatrist, or meets the cut-off score of ? 12 in the PHQ- 9 or a cut-off of ? 15 in the GAD-7 mood scale for reasons not attributable to GBM; or selects a positive response of '1, 2, 3' to question number 9 regarding potential for suicidal thoughts or ideation in the PHQ-9 (independent of the total score of the PHQ-9)
Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as result of patient's mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* At screening, mood rating scores of >= 10 on Patient Health Questionnaire (PHQ)-9 and/or >= 15 on Generalized Anxiety Disorder Scale (GAD)-7, unless overruled by psychiatrist's assessment\r\n* Patient selects a response of \1, 2, or 3\ for question 9 on PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)\r\n* NOTE: the psychiatric judgment overrules the mood assessment questionnaire result/investigators judgment; if mood rating scores do not meet eligibility criteria and/or the investigator deems that a patient has mood disorder that renders the patient ineligible, that patient may not be registered to the study unless there is a subsequent psychiatric clinic consultation in which the psychiatrist overrules the mood assessment questionnaire result/investigator judgment
Patient has a score >= 12 on the Patient Health Questionnaire (PHQ)-9 questionnaire
Patient selects a response of “1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)
Score of < 9 on the PHQ-4
No suicidal thoughts as indicated by a positive (1+) response to question 9 on the PHQ9
Score >= 10 on the Generalized Anxiety Disorder-7 Questionnaire (GAD-7) and/or a score >= 8 on the Patient Health Questionnaire-9 Item (PHQ-9), indicating clinically significant anxiety or depressive symptoms, respectively
Having a psychotic disorder or the presence of another psychiatric condition (e.g., severe depression [i.e., > 19 on the Patient Health Questionnaire-9 [PHQ-9]], suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study
Positive depression screen (PHQ-9 score >= 8) or current antidepressant treatment
A score of 25 or more on the Patient Health Questionnaire (PHQ-9) on the first visit
Severe depression (Patient Health Questionnaire [PHQ]-8 >= 20)
Suicidal ideation, as determined via Patient Health Questionnaire (PHQ)-9
Participants with major depressive disorder and/or suicidal ideation as determined by PHQ-9
Scores 20 or above on the patient health questionnaire (PHQ)-8 depression measure (indicating severe depression); these participants will be contacted by a study psychologist to evaluate and provide resources to address their needs (2% of enrollees in our previous study); they will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment
Currently elevated depressive symptoms; (Patient Health Questionnaire [PHQ] 2 > 2)
Meeting criteria for a current major depressive episode measured by the PHQ-9