Overview

Study of Methylphenidate as Add on Therapy in Depressed Cancer Patients

Status:
Unknown status

Trial end date:
2012-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Malaya

Treatments:

Methylphenidate
Mianserin
Mirtazapine

Criteria

Inclusion Criteria:

1. Male or female, aged >18 years.

2. Current DSM IV diagnosis of Major Depressive Disorder.

3. Under palliative care.

4. Confirmed diagnosis of cancer.

5. Not on any antidepressants

Exclusion Criteria:

1. Clinical significant abnormal laboratory values.

2. Clinically significant abnormal ECG.

3. Documented history of other psychiatric diagnosis (schizophrenia, bipolar disorder,
organic brain disorder, dementia etc.)