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Study of Methylphenidate as Add on Therapy in Depressed Cancer Patients

This study is currently recruiting participants.
Verified December 2011 by University of Malaya
Sponsor:
Information provided by (Responsible Party):
Dr Ng Chong Guan, University of Malaya
ClinicalTrials.gov Identifier:
NCT01497548
First received: February 24, 2011
Last updated: December 21, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Depression
 Drug: Methylphenidate
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Parallel-group, Double-blind, Placebo-controlled Study of Methylphenidate as an Add on Therapy for Mirtazapine in the Treatment of Major Depressive Disorder in Cancer Patients Under Palliative Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Malaya:

Primary Outcome Measures:
  • depressive symptoms [ Time Frame: 3 to 28 days ] [ Designated as safety issue: No ]
    measured with Montgomery-Åsberg Depression Rating Scale


Secondary Outcome Measures:
  • Distress level [ Time Frame: 3 to 28 days ] [ Designated as safety issue: No ]
    Measured with distress thermometer


Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate add on to Mirtazapine
Methylphenidate add on to the usual treatment (Mirtazapine)
 Drug: Methylphenidate
Methylphenidate started at 5mg on morning (0800) and noon (1200) on day 1. Dose increased to 10mg on morning (0800) and noon (1200) on day 3; 15mg on morning and noon on day 6 depending on the clinical response. Similarly, the dose can be reduced to 5mg/day if patients are not able to tolerate a higher dose. The treatment continues until day 28.
Other Name: Ritalin
Placebo Comparator: Placebo add on to Mirtazapine
Non active compund add on to the usual treatment (Mirtazapine)
 Drug: Placebo
Placebo given on morning (0800) and noon (1200)daily
Other Name: Non active compound

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497548

Contacts
Contact: Chong Guan Ng, MBBS, MPM 60379604367 chong_guan@hotmail.com

Locations
Malaysia
University Malaya Medical Centre Not yet recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Chong Guan Ng, MBBS, MPM     60379604367     chong_guan@hotmail.com    
Principal Investigator: Chong Guan Ng, MBBS, MPM            
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Chong Guan Ng, MBBS, MPM     0379492068     chong_guan1975@yahoo.co.uk    
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: Chong Guan Ng, MBBS, MPM Department of Psychological Medicine, University Malaya Medical Centre
  More Information

Publications:

Responsible Party: Dr Ng Chong Guan, Principal Investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT01497548     History of Changes
Other Study ID Numbers: NCG001
Study First Received: February 24, 2011
Last Updated: December 21, 2011
Health Authority: Malaysia: Medical Ethical Comittee, University Malaya Medical Centre

Keywords provided by University of Malaya:
Depression
cancer
methylphenidate
pharmacotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Methylphenidate
Mirtazapine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
 Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on June 18, 2013