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Study of Methylphenidate as Add on Therapy in Depressed Cancer Patients

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ClinicalTrials.gov Identifier: NCT01497548
Recruitment Status : Unknown
Verified December 2011 by Dr Ng Chong Guan, University of Malaya.
Recruitment status was:  Recruiting
First Posted : December 22, 2011
Last Update Posted : December 22, 2011
Sponsor:
Information provided by (Responsible Party):
Dr Ng Chong Guan, University of Malaya

Brief 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.


Condition or disease Intervention/treatment Phase
Depression Drug: Methylphenidate Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. depressive symptoms [ Time Frame: 3 to 28 days ]
    measured with Montgomery-Åsberg Depression Rating Scale


Secondary Outcome Measures :
  1. Distress level [ Time Frame: 3 to 28 days ]
    Measured with distress thermometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497548


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

Locations
Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Chong Guan Ng, MBBS, MPM    0379492068    chong_guan1975@yahoo.co.uk   
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         
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: Chong Guan Ng, MBBS, MPM Department of Psychological Medicine, University Malaya Medical Centre

Publications:
Massie, M.J., Popkin, M.K. Depressive Disorders. In: Holland, J.C. (Eds), Psycho-oncology. Oxford University Press, NY 1998; 518-519.
Marek Kaminski, Per Sjogren. The Use of psychostimulants in palliative and supportive treatment of cancer patients. Advances in Palliative Medicine 2007; 6: 23-31.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Ng Chong Guan, Principal Investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT01497548     History of Changes
Other Study ID Numbers: NCG001
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: December 2011

Keywords provided by Dr Ng Chong Guan, University of Malaya:
Depression
cancer
methylphenidate
pharmacotherapy

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Methylphenidate
Mirtazapine
Mianserin
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation