Study of Methylphenidate as Add on Therapy in Depressed Cancer Patients

NCT01497548 | Unknown Phase 3

• 1 other identifier: NCG001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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. 1.To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the treatment of anxiety in cancer patients under palliative care.
2. 2.To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in reducing distress in cancer patients under palliative care.
3. 3.To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in improving function in cancer patients under palliative care.
4. 4.To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in reducing somatic complaints in cancer patients under palliative care.

Conditions

Depression

Keywords

Depression; cancer; methylphenidate; pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• depressive symptoms

  measured with Montgomery-Åsberg Depression Rating Scale

  3 to 28 days

Secondary Outcomes (1)

• Distress level

  3 to 28 days

Study Arms (2)

Methylphenidate add on to Mirtazapine

EXPERIMENTAL

Methylphenidate add on to the usual treatment (Mirtazapine)

Drug: Methylphenidate

Placebo add on to Mirtazapine

PLACEBO COMPARATOR

Non active compund add on to the usual treatment (Mirtazapine)

Drug: Placebo

Interventions

Methylphenidate DRUG

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.

Also known as: Ritalin

Methylphenidate add on to Mirtazapine

Placebo DRUG

Placebo given on morning (0800) and noon (1200)daily

Also known as: Non active compound

Placebo add on to Mirtazapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged \>18 years.
• Current DSM IV diagnosis of Major Depressive Disorder.
• Under palliative care.
• Confirmed diagnosis of cancer.
• Not on any antidepressants

You may not qualify if:

• Clinical significant abnormal laboratory values.
• Clinically significant abnormal ECG.
• Documented history of other psychiatric diagnosis (schizophrenia, bipolar disorder, organic brain disorder, dementia etc.)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (2)

University Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

RECRUITING

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

NOT YET RECRUITING

Related Publications (21)

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• 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. doi: 10.1002/cncr.21532.

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• Massie, M.J., Popkin, M.K. Depressive Disorders. In: Holland, J.C. (Eds), Psycho-oncology. Oxford University Press, NY 1998; 518-519.

  BACKGROUND

• Chochinov HM. Depression in cancer patients. Lancet Oncol. 2001 Aug;2(8):499-505. doi: 10.1016/S1470-2045(01)00456-9.

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• 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.

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• 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. doi: 10.1001/archpsyc.1995.03950140007002.

  PMID: 7848055 BACKGROUND

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  PMID: 17288583 BACKGROUND

• Challman TD, Lipsky JJ. Methylphenidate: its pharmacology and uses. Mayo Clin Proc. 2000 Jul;75(7):711-21. doi: 10.4065/75.7.711.

  PMID: 10907387 BACKGROUND

• Raison CL, Miller AH. Depression in cancer: new developments regarding diagnosis and treatment. Biol Psychiatry. 2003 Aug 1;54(3):283-94. doi: 10.1016/s0006-3223(03)00413-x.

  PMID: 12893104 BACKGROUND

• 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. doi: 10.1007/s00520-006-0145-3. Epub 2006 Oct 21.

  PMID: 17058100 BACKGROUND

• 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. doi: 10.1200/JCO.2002.20.1.335.

  PMID: 11773187 BACKGROUND

• Marek Kaminski, Per Sjogren. The Use of psychostimulants in palliative and supportive treatment of cancer patients. Advances in Palliative Medicine 2007; 6: 23-31.

  BACKGROUND

• Masand PS, Tesar GE. Use of stimulants in the medically ill. Psychiatr Clin North Am. 1996 Sep;19(3):515-47. doi: 10.1016/s0193-953x(05)70304-x.

  PMID: 8856815 BACKGROUND

• 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.

  PMID: 18425966 BACKGROUND

• 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. doi: 10.1016/0885-3924(94)00080-5.

  PMID: 7730689 BACKGROUND

• 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.

  PMID: 18304907 BACKGROUND

• Ng CG, Boks MP, Roes KC, Zainal NZ, Sulaiman AH, Tan SB, de Wit NJ. Rapid response to methylphenidate as an add-on therapy to mirtazapine in the treatment of major depressive disorder in terminally ill cancer patients: a four-week, randomized, double-blinded, placebo-controlled study. Eur Neuropsychopharmacol. 2014 Apr;24(4):491-8. doi: 10.1016/j.euroneuro.2014.01.016. Epub 2014 Jan 20.

  PMID: 24503279 DERIVED

MeSH Terms

Conditions

Depression; Neoplasms

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chong Guan Ng, MBBS, MPM

  Department of Psychological Medicine, University Malaya Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chong Guan Ng, MBBS, MPM

CONTACT

60379604367; chong_guan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: December 22, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 22, 2011

Record last verified: 2011-12

Locations

MY (2)