Remission of depressive episode at Visit 6 by Hamilton Depression Rating Scale
Remission of depressive episode after the last IV treatment (measured objectively at Visit 6), and is defined as occurring when an individual has:
a Hamilton Depression Rating Scale score ≤7 (note range of scores are from 0-53 with lower scores indicating less symptoms of depression and better outcome).
Remission of depressive episode at Visit 6 by Montgomery and Asberg Depression Rating Scale
Remission of depressive episode after the last IV treatment (measured objectively at Visit 6), and is defined as occurring when an individual has:
a Montgomery and Asberg Depression Rating Scale score <6 (note range of scores are from 0-60 with lower scores indicating less symptoms of depression and better outcome).
Remission of depressive episode at Visit 7 by the Hamilton Depression Rating Scale
Remission of depressive episode at follow-up (measured objectively at Visit 7) a Hamilton Depression Rating Scale score ≤7 (note range of scores are 0-53 with lower scores indicating less symptoms of depression and better outcome).
Remission of depressive episode at Visit 7 by the Montgomery and Asberg Depression Rating Scale
Remission of depressive episode at follow-up (measured objectively at Visit 7) a Montgomery and Asberg Rating Scale score <6 (Note range of scores are from 0-60 with lower scores indicating less symptoms of depression and better outcome).
Improvement in overall functioning utilising the Global Assessment of Functioning Scale
Improvement in objectively measured overall functioning, measured with the Global Assessment of Functioning Scale at Visit 6 (note range of scores are from 0-100, with higher scores indicating better overall functioning and better outcome)
Improvement in overall functioning utilising the Global Assessment of Functioning Scale
Improvement in objectively measured overall functioning, measured with the Global Assessment of Functioning Scale at Visit 7 (note range of scores are 0-100, with higher scores indicating better overall functioning and better outcome).
Improvement in objectively rated illness severity using Clinical Global Impression
Improvement in objectively rated illness severity, measured with the Clinical Global Impression Scale - Improvement at Visit 6 (note range of scores are 1-7, with lower scores (1-3) indicating improved outcome and higher scores (5-7) indicating a worse outcome. A score of 4 indicates no change in symptoms).
Improvement in objectively rated illness severity using Clinical Global Impression
Improvement in objectively rated illness severity, measured with the Clincial Global Impression Improvement Scale at Visit 7 (note range of scores are from 1-7 with lower scores indicating improved outcome).
Change in depressive symptoms with the Profile of Mood Scores
Change in subjective measured depressive symptoms with the Profile of Mood Scores. A reduction in the Profile of Mood Score for depression post-infusion compared to pre-infusion at visits 2 indicates less depressive symptoms and improved outcome (note range of scores are 0-4 with lower scores indicating less depressive symptoms).
Change in total mood disturbance with the Profile of Mood Scores
Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores. A reduction in the Profile of Mood Score for total mood disturbance post-infusion compared to pre-infusion at visits 2 indicates less disturbance of mood symptoms and improved outcome (note range of scores are 0-20) with lower scores indicating lower levels of mood disturbance and improved outcome.
Change in depressive symptoms with the Profile of Mood Scores
Change in subjective measured depressive symptoms with the Profile of Mood Score for depression at follow-up visit 6 (note range of scores are 0-4 with lower scores indicating less depressive symptoms and improved outcome).
Change in depressive symptoms with the Profile of Mood Scores
Change in subjective measured depressive symptoms with the Profile of Mood Scores for Depression at follow-up visit 7 (note range of scores are 0-4 with lower scores indicating less depressive symptoms and improved outcome).
Change in total mood disturbance symptoms with the Profile of Mood Scores
Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores for Depression at follow-up visit 6 (note range of scores are 0-20 with lower scores indicating lower levels of mood disturbance and improved outcome).
Change in total mood disturbance with the Profile of Mood Scores
Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores for Depression at follow-up visit 7 (note range of scores are 0-20 with lower scores indicating lower levels of mood disturbance and improved outcome).
Change in symptoms of anger with the Profile of Mood Scores
Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger at follow-up Visit 6 (note range of scores are 0-4 with lower scores indicating less anger and improved outcome).
Change in symptoms of anger with the Profile of Mood Scores
Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger at follow-up Visit 7 (note range of scores are 0-4 with lower scores indicating less anger and improved outcome).
Change in symptoms of anger with the Profile of Mood Scores
Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger. A reduction in Profile of Mood Score for Anger score post-infusion compared to pre-infusion at visits 2 indicating less anger and improved outcome with range of scores of 0-4).
Change in symptoms of tension with the Profile of Mood Scores
Change in subjective measured symptoms of tension with the POMS - Tension. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.
3, 4 and 5.
Change in symptoms of tension with the Profile of Mood Scores
Change in subjective measured symptoms of tension using the Profile of Mood Scores - Tension at follow-up Visit 6. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.
Change in symptoms of tension with the Profile of Mood Scores
Change in subjective measured symptoms of tension using the Profile of Mood Scores - Tension at follow-up Visit 7. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.
Change in symptoms of fatigue with the Profile of Mood Scores
Change subjective measured symptoms of fatigue with the Profile of Mood Scores - Fatigue. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.
3, 4 and 5.
Change in symptoms of fatigue with the Profile of Mood Scores
Change in subjective measured symptoms of fatigue using the Profile of Mood Scores - Fatigue at follow-up Visit 6. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.
Change in symptoms of fatigue with the Profile of Mood Scores
Change in subjective measured symptoms of fatigue at follow-up Visit 7. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.
Change in symptoms of vigour with the Profile of Mood Scores
Changing subjective measured symptoms of vigour with the Profile of Mood Scores. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour andimproved outcome, with scores ranging from 0-4.
Change in symptoms of vigour with the Profile of Mood Scores
Change in subjective measured symptoms of vigour at follow-up Visit 6 measured with the Profile of Mood Scores - Vigour. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour improved outcome, with scores ranging from 0-4.
Change in symptoms of vigour with the Profile of Mood Scores
Change in subjective measured symptoms of vigour at follow-up Visit 7. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour and improved outcome, with scores ranging from 0-4.
Change in symptoms of confusion with the Profile of Mood Scores
Change in subjective measured symptoms of confusion with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.
3, 4 and 5.
Change in symptoms of confusion with the Profile of Mood Scores
Change in subjective measured symptoms of confusion at follow-up Visit 6 measured with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.
Change in symptoms of confusion with the Profile of Mood Scores
Change in subjective measured symptoms of confusion at follow-up Visit 7 measured with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.
Change in happiness scores with the Visual Analogue Scale
A change in subjectively measured levels of happiness as measured with the Visual Analogue Scale for happiness. Higher scores indicate increased happiness and improved outcome, with scores ranging from 0-10.
Change in restlessness symptoms with the Visual Analogue Scale
A change in subjectively measured levels of restlessness as measured with the Visual Analogue Scale for Restlessness. Lower scores indicate reduced restlessness and improved outcome, with scores ranging from 0-10.
Change in sadness symptoms with the Visual Analogue Scale
A change in subjectively measured levels of sadness as measured with the Visual Analogue Scale for sadness. Lower scores indicate reduced sadness and improved outcome, with scores ranging from 0-10.
Change in anxiety with the Visual Analogue Scale
A change in subjectively measured levels of anxiety as measured with the Visual Analogue Scale for Anxiety. Lower scores indicate reduced anxiety and improved outcome, with scores ranging from 0-10.
Change in anger with the Visual Analogue Scale
A change in subjectively measured levels of anger as measured with the Visual Analogue Scale for Anger. Lower scores indicate reduced anger and improved outcome, with scores ranging from 0-10.
Change in drowsiness with the Visual Analogue Scale
A change in subjectively measured levels of drowsiness as measured with the Visual Analogue Scale. Lower scores indicate reduced drowsiness and improved outcome, with scores ranging from 0-10.
Change in alertness with the Visual Analogue Scale (VAS)
A change in subjectively measured levels of alertness as measured with the Visual Analogue Scale for alertness. Higher scores indicate increased alertness and improved outcome, with scores ranging from 0-10.
Number of participants admitted to a psychiatric inpatient unit
Psychiatric inpatient admission of a participant due to depressive episodes during the trial (Visits 2 to 7)
Change in antidepressant use
Antidepressants medication use or change by a participant due to depressive episodes over the duration of the study (Visit 2 to Visit 7):
(i) Introduction of a new antidepressant (yes / no) (ii) Increase in dose of an existing antidepressant (yes / no)
Change in executive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Change in executive functioning using the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Change in visual processing - CANTAB
Change in visual processing the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Change in motor processing - CANTAB
Change in motor processing utilising the CANTAB
Change in emotion recognition - CANTAB
Change in emotion recognition utilising the CANTAB
Occurrence of a hypo (manic) episodes measured by the Young Mania Rating Scale
Occurrence of a hypo (manic) episodes by the YMRS during study
Occurrence of adverse effects - bradycardia
Occurrence of bradycardia - measured at each visit post-infusion
Occurrence of adverse effects - hypotension
Occurrence of hypotension - measured at each visit post-infusion
Occurrence of adverse effects reported by patient
Occurrence of adverse effects reported by patient at visits 2,3,4,5,6,7
Occurrence of adverse effects using Patient Rated Inventory of Side Effects (PRISE)
Occurrence of adverse effects as reported by participants or measured utilising the PRISE questionnaire