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Study of Methylphenidate as Add on Therapy in Depressed Cancer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Dr Ng Chong Guan, University of Malaya.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497548
First Posted: December 22, 2011
Last Update Posted: December 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Ng Chong Guan, University of Malaya
  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
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

Resource links provided by NLM:


Further study details as provided by Dr Ng Chong Guan, University of Malaya:

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


Secondary Outcome Measures:
  • Distress level [ Time Frame: 3 to 28 days ]
    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

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.)
  Contacts and Locations
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
  More Information

Publications:
Knobf MT. Psychosocial responses in breast cancer survivors. Semin Oncol Nurs. 2007 Feb;23(1):71-83. Review.
Derogatis LR, Morrow GR, Fetting J, Penman D, Piasetsky S, Schmale AM, Henrichs M, Carnicke CL Jr. The prevalence of psychiatric disorders among cancer patients. JAMA. 1983 Feb 11;249(6):751-7.
Somerset W, Stout SC, Miller AH, Musselman D. Breast cancer and depression. Oncology (Williston Park). 2004 Jul;18(8):1021-34; discussion 1035-6, 1047-8. Review.
Bennett B, Goldstein D, Lloyd A, Davenport T, Hickie I. Fatigue and psychological distress--exploring the relationship in women treated for breast cancer. Eur J Cancer. 2004 Jul;40(11):1689-95.
Green CR, Montague L, Hart-Johnson TA. Consistent and breakthrough pain in diverse advanced cancer patients: a longitudinal examination. J Pain Symptom Manage. 2009 May;37(5):831-47. doi: 10.1016/j.jpainsymman.2008.05.011. Epub 2008 Dec 2.
Kadan-Lottick NS, Vanderwerker LC, Block SD, Zhang B, Prigerson HG. Psychiatric disorders and mental health service use in patients with advanced cancer: a report from the coping with cancer study. Cancer. 2005 Dec 15;104(12):2872-81.
Massie, M.J., Popkin, M.K. Depressive Disorders. In: Holland, J.C. (Eds), Psycho-oncology. Oxford University Press, NY 1998; 518-519.
Chochinov HM. Depression in cancer patients. Lancet Oncol. 2001 Aug;2(8):499-505. Review.
Fann JR, Thomas-Rich AM, Katon WJ, Cowley D, Pepping M, McGregor BA, Gralow J. Major depression after breast cancer: a review of epidemiology and treatment. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):112-26. doi: 10.1016/j.genhosppsych.2007.10.008. Review.
McDaniel JS, Musselman DL, Porter MR, Reed DA, Nemeroff CB. Depression in patients with cancer. Diagnosis, biology, and treatment. Arch Gen Psychiatry. 1995 Feb;52(2):89-99. Review.
Pasquini M, Biondi M. Depression in cancer patients: a critical review. Clin Pract Epidemiol Ment Health. 2007 Feb 8;3:2.
Challman TD, Lipsky JJ. Methylphenidate: its pharmacology and uses. Mayo Clin Proc. 2000 Jul;75(7):711-21. Review.
Raison CL, Miller AH. Depression in cancer: new developments regarding diagnosis and treatment. Biol Psychiatry. 2003 Aug 1;54(3):283-94. Review.
Rodin G, Lloyd N, Katz M, Green E, Mackay JA, Wong RK; Supportive Care Guidelines Group of Cancer Care Ontario Program in Evidence-Based Care. The treatment of depression in cancer patients: a systematic review. Support Care Cancer. 2007 Feb;15(2):123-36. Epub 2006 Oct 21. Review.
Rozans M, Dreisbach A, Lertora JJ, Kahn MJ. Palliative uses of methylphenidate in patients with cancer: a review. J Clin Oncol. 2002 Jan 1;20(1):335-9. Review.
Marek Kaminski, Per Sjogren. The Use of psychostimulants in palliative and supportive treatment of cancer patients. Advances in Palliative Medicine 2007; 6: 23-31.
Masand PS, Tesar GE. Use of stimulants in the medically ill. Psychiatr Clin North Am. 1996 Sep;19(3):515-47. Review.
Candy M, Jones L, Williams R, Tookman A, King M. Psychostimulants for depression. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006722. doi: 10.1002/14651858.CD006722.pub2. Review.
Vigano A, Watanabe S, Bruera E. Methylphenidate for the management of somatization in terminal cancer patients. J Pain Symptom Manage. 1995 Feb;10(2):167-70.
Laval G, Paris A. [Methylphenidate in palliative care in cancer patient: a double-blind randomised trial versus placebo]. Bull Cancer. 2008 Feb;95(2):241-6. doi: 10.1684/bdc.2008.0581. French.

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 Submitted: February 24, 2011
First Posted: December 22, 2011
Last Update Posted: December 23, 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


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