Study of Methylphenidate as Add on Therapy in Depressed Cancer Patients
Status:
Unknown status
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
Primary Objective To determine the efficacy of Methylphenidate as add on therapy to
mirtazapine in the treatment of depression in cancer patients under palliative care
Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early
reduction in (Montgomery Asberg Depression Rating Scale) MADRS between baseline and Day 3.
Secondary Objective
1. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the
treatment of anxiety in cancer patients under palliative care.
Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant
early reduction in anxiety score of HADS than Mirtazepine alone treated subjects between
baseline and Day 3.
2. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in
reducing distress in cancer patients under palliative care.
Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant
early reduction in distress score of distress thermometer than Mirtazepine alone treated
subjects between baseline and Day 3.
3. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in
improving function in cancer patients under palliative care.
Hypothesis Methyphenidate add on to mirtazapine treated subjects will show increase in
the (Eastern Cooperation Group performance status) ECOG score than Mirtazepine alone
treated subjects between baseline and Day 3
4. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in
reducing somatic complaints in cancer patients under palliative care.
Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early
reduction in the score of Numeric Rating Scale (NRS) for Pain and Visual Analogue Scale (VAS)
for Fatigue than Mirtazapine alone treated subjects between baseline and Day 3.