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Research Article

A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury: Methods and lessons learned

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References

  • Elliott TR, Frank RG. Depression following spinal cord injury. Arch Phys Med Rehabil 1996;77(8):816–23.
  • Frank RG, Elliott TR, Corcoran J, Wonderlich S. Depression after spinal cord injury: is it necessary? Clin Psychol Rev 1987;7(6):611–30.
  • Frank RG, Wonderlich SA. Depression in spinal cord injured patients. Paraplegia 1981;19(5):284–8.
  • Craig A, Tran Y, Middleton J. Psychological morbidity and spinal cord injury: a systematic review. Spinal Cord 2009;47(2):108–14.
  • Herrick S, Elliott T, Crow F. Social support and the prediction of health complications among persons with spinal cord injury. Rehabil Psychol 1994;39(4):231–50.
  • Schulz R, Decker S. Long-term adjustment to physical disability: the role of social support, perceived control, and self-blame. J Pers Soc Psychol 1985;48(5):1162–72.
  • Elliott TR, Shewchuk RM. Social support and leisure activities following severe physical-disability – testing the mediating effects of depression. Basic Appl Soc Psych 1995;16(4):471–87.
  • Fuhrer MJ, Rintala DH, Hart KA, Clearman R, Young ME. Depressive symptomatology in persons with spinal cord injury who reside in the community. Arch Phys Med Rehabil 1993;74(3):255–60.
  • MacDonald MR, Nielson W, Cameron M. Depression and activity patterns of spinal cord injury persons living in the community. Arch Phys Med Rehabil 1987;68:339–43.
  • Scivoletto G, Petrelli A, Di Lucente L, Castellano V. Psychological investigation of spinal cord injury patients. Spinal Cord 1997;35(8):516–20.
  • Krause JS, Zhai Y, Saunders LL, Carter RE. Risk of mortality after spinal cord injury: an 8-year prospective study. Arch Phys Med Rehabil 2009;90(10):1708–15.
  • Kemp BJ, Kahan JS, Krause JS, Adkins RH, Nava G. Treatment of major depression in individuals with spinal cord injury. J Spinal Cord Med 2004;27(1):22–8.
  • Fullerton D, Harvey R, Klein M, Howell T. Psychiatric disorders in patients with spinal cord injury. Arch Gen Psychiatry 1981;38(12):1369–71.
  • Judd FK, Burrows GD, Brown DJ. Depression following acute spinal cord injury. Paraplegia 1986;24(6):358–63.
  • Judd FK, Stone J, Webber JE, Brown DJ, Burrows GD. Depression following spinal cord injury. A prospective in-patient study. Br J Psychiatry 1989;154:668–71.
  • Kim SP, Davis SW, Sell GH. Amitriptyline in severely depressed spinal cord-injured patients: rapidity of response. Arch Phys Med Rehabil 1977;58(4):157–61.
  • Duchnick JJ, Letsch EA, Curtiss G. Coping effectiveness training during acute rehabilitation of spinal cord injury/dysfunction: a randomized clinical trial. Rehabil Psychol 2009;54(2):123–32.
  • Hicks AL, Martin KA, Dito DS, Latimer AE, Craven C, Bugaresti J, et al. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord 2003;41(1):34–43.
  • Diego MA, Field T, Hernandez-Reif M, Hart S, Brucker B, Burman I. Spinal cord patients benefit from massage therapy. Int J Neurosci 2002;112(2):133–42.
  • Craig AR, Hancock K, Dickson H, Chang E. Long-term psychological outcomes in spinal cord injured persons: results of a controlled trial using cognitive behaviora therapy. Arch Phys Med Rehabil 1997;78(1):33–8.
  • Kennedy P, Duff J, Evans M, Beedie A. Coping effectiveness training reduces depression and anxiety following traumatic spinal cord injuries. Br J Clin Psychol 2003;42(Pt 1):41–52.
  • King C, Kennedy P. Coping effectiveness training for people with spinal cord injury: preliminary results of a controlled trail. Br J Clin Psychol 1999;38(Pt1):5–14.
  • Elliott TR, Kennedy P. Treatment of depression following spinal cord injury: an evidence-based review. Rehabil Psychol 2004;49(2):134–9.
  • Werhagen L, Budh CN, Hultling C, Molander C. Neuropathic pain after traumatic spinal cord injury – relations to gender, spinal level, completeness, and age at the time of injury. Spinal Cord 2004;42(42):665–73.
  • Fann JR, Bombardier CH, Richards JS, Tate DG, Wilson CS, Temkin N, et al. Depression after spinal cord injury: comorbidities, mental health service use, and adequacy of treatment. Arch Phys Med Rehabil 2011;92(3):352–60.
  • The Consortium of Spinal Cord Medicine. Depression following spinal cord injury: a clinical practice guideline for primary care physicians. Washington, DC; 1998.
  • Lesperance F, Frasure-Smith N, Koszycki D, Laliberte MA, van Zyl LT, Baker B, et al. Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the canadian cardiac randomized evaluation of antidepressant and psychotherapy efficacy (create) trial. JAMA 2007;297(4):367–79.
  • Glassman AH, O'Connor CM, Claiff RM, Swedberg K, Schwartz P, Bigger JTJ, et al. Sertraline treatment of major depression in patients with acute mi or unstable angina. JAMA 2002;288(6):701–9.
  • Lustman PJ, Freedland KE, Griffith LS, Clouse RE. Fluoxetine for depression in diabetes: a randomized double-blind placebo-controlled trial. Diabetes Care 2000;23(5):618–23.
  • Lustman PJ, Griffith LS, Clouse RE, Freedland KE, Eisen SA, Rubin EH, et al. Effects of nortriptyline on depression and glycemic control in diabetes: results of a double-blind placebo-controlled trial. Psychosom Med 1997;59(3):241–50.
  • Rabkin JG, Rabkin R, Harrison W, Wagner G. Effect of imipramine on mood and enumerative measures of immune status in depressed patients with HIV illness. Am J Psychiatry 1994;151(4):516–23.
  • Robinson RG, Schultz SK, Castillo C. Nortriptyline versus fluoxetine in the treatment of depression and in short-term recovery after stroke: a placebo-controlled, double-blind study. Am J Psychiatry 2000;157(3):351–9.
  • Cardenas DD, Hoffman JM, Kirshblum S, McKinley W. Etiology and incidence of rehospitalization after traumatic spinal cord injury: a multicenter analysis. Arch Phys Med Rehabil 2004;85(11):1757–63.
  • Iosifescu DV. Treating depression in the medically ill. Psychiat Clin N Am 2007;30(1):77–90.
  • Macciocchi S, Seel RT, Thompson N, Byams R, Bowman B. Spinal cord injury and co-occurring traumatic brain injury: assessment and incidence. Arch Phys Med Rehabil 2008;89(7):1350–7.
  • Dinan TG, Mobayed M. Treatment resistance of depression after head injury: a preliminary study of amitriptyline response. Acta Psychiatrica Scandinavica 1992;85(4):292–4.
  • Reynolds CF, Miller MD, Pasternak RE. Treatment of bereavement-related major depressive episodes in later life: a controlled study of acute and continuation treatment with nortriptyline and interpersonal psychotherapy. Am J Psychiatry 1999;156(2):202–8.
  • Bair MJ, Robinson RL, Katon W, Kroenke K. Depression and pain comorbidity: a literature review. Arch Intern Med 2003;163(20):2433–45.
  • Krause JS, Kewman D, DeVivo MJ, Maynard F, Coker J, Roach MJ, et al. Employment after spinal cord injury: an analysis of cases from the model spinal cord injury systems. Arch Phys Med Rehabil 1999;80(11):1492–500.
  • Cohen A, Houck PR, Szanto K, Dew MA, Gilman SE, Reynolds CF. Social inequalities in response to antidepressant treatment in older adults. Arch Gen Psychiatry 2006;63(1):50–6.
  • Bosworth HB, Hays JC, George LK, Steffens DC. Psychosocial and clinical predictors of unipolar depression outcome in older adults. Int J Geriat Psychiatry 2002;17(3):238–46.
  • Devivo MJ, Hawkins LN, Richards JS, Go BK. Outcomes of post-spinal cord injury marriages. Arch Phys Med Rehabil 1995;76(2):130–8.
  • Stolp-Smith KA, Wainberg MC. Antidepressant exacerbation of spasticity. Arch Phys Med Rehabil 1999;80(3):339–42.
  • Wainberg MC, Barbeau H, Gauthier S. The effects of cyproheptadine on locomotion and on spasticity in patients with spinal cord injuries. J Neurol Neurosurg Psychiatry 1990;53(9):754–63.
  • Smith BM, Weaver FM, Ullrich PM. Prevalence of depression diagnoses and use of antidepressant medications by veterans with spinal cord injury. Am J Phys Med Rehabil 2007;86(8):662–71.
  • Federoff J, Lipsey J, Starkstein S, Forrester A, Price T, Robinson R. Phenomenological comparisons of major depression following stroke, myocardial infarction or spinal cord injury. J Affect Disord 1991;22(1-2):83–9.
  • Putzke JD, Richards JS, Dowler RN. The impact of pain in spinal cord injury: a case-control study. Rehabil Psychol 2000;45(4):386–401.
  • Price GL, Kendall M, Amsters DI, Pershouse KJ. Perceived causes of change in function and quality of life for people with long duration spinal cord injury. Clin Rehabil 2004;18(2):164–71.
  • Stormer S, Gerner HJ, Gruninger W. Chronic pain/dysaesthsiae in spinal cord injury patients: results of a multicentre study. Spinal Cord 1997;35(7):446–55.
  • Turner JA, Cardenas DD. Chronic pain problems in individuals with spinal cord injuries. Semin Clin Neuropsychiatry 1999;4(3):186–94.
  • Elliott TR, Harkins SW. Psychosocial concomitants of persistent pain among persons with spinal cord injuries. NeuroRehabilitation 1991;1(4):7–16.
  • Summers JD, Rapoff MA, Varghese G, Porter K, Palmer RE. Psychosocial factors in chronic spinal cord injury pain. Pain 1991;47(2):183–9.
  • Cairns DM, Adkins RH, Scott MD. Pain and depression in acute traumatic spinal cord injury: origins of chronic problematic pain? Arch Phys Med Rehabil 1996;77(4):329–35.
  • Craig AR, Hancock KM, Dickson HG. A longitudinal investigation into anxiety and depression in the first 2 years following a spinal cord injury. Paraplegia 1994;32(10):675–9.
  • Cardenas DD, Warms CA, Turner JA, Marshall H, Brooke MM, Loeser JD. Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial. Pain 2002;96(3):365–73.
  • Rintala DH, Holmes SA, Courtade D, Fiess RN, Tastard LV, Loubser PG. Comparison of the effectiveness of amitriptyline and gabapentin on chronic neuropathic pain in persons with spinal cord injury. Arch Phys Med Rehabil 2007;88(12):1547–60.
  • Max MB, Lynch SA, Muir J, Shoaf SE, Snikkerm B, Dubner R. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. New Engl J Med 1992;326(19):1250–6.
  • Guelfi JD, White C, Hackett D, Guichoux JY, Magni G. Effectiveness of venlafaxine in patients hospitalized for major depression and melancholia. J Clin Psychiatry 1995;56(10):450–8.
  • Thase ME. Efficacy and tolerability of once-daily venlafaxine extended release (XR) in outpatients with major depression. The venlafaxine XR 209 study group. J Clin Psychiatry 1997;58(9):393–8.
  • Golden RN, Nicholas L. Antidepressant efficacy of venlafaxine. Depress Anxiety 2000;12(Suppl 1):45–9.
  • Thase ME, Entsuah AR, Rudolph RL. Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry 2001;178:234–41.
  • Cunningham LA. Once-daily venlafaxine extended release (xr) and venlafaxine immediate release (IR) in outpatients with major depression. Venlafaxine xr 208 study group. Ann Clin Psychiatry 1997;9(3):157–64.
  • Feighner JP, Entsuah AR, McPherson MK. Efficacy of once-daily venlafaxine extended release (XR) for symptoms of anxiety in depressed outpatients. J Affect Disord 1998;47(1–3):55–62.
  • Dierick M, Ravizza L, Realini R, Martin A. A double-blind comparison of venlafaxine and fluoxetine for treatment of major depression in outpatients. Prog Neuropsychopharmacol Biol Psychiatry 1996;20(1):57–71.
  • Davis JL, Smith RL. Painful peripheral diabetic neuropathy treated with venlafaxine HCL extended release capsules. Diabetes Care 1999;22(11):1909–10.
  • Dwight MM, Arnold LM, O'Brien H, Metzger R, Morris-Park E, Keck PE, Jr. An open clinical trial of venlafaxine treatment of fibromyalgia. Psychosomatics 1998;39(1):14–7.
  • Lang E, Hord AH, Denson D. Venlafaxine hydrochloride (effexor) relieves thermal hyperalgesia in rats with an experimental mononeuropathy. Pain 1996;68(1):151–5.
  • Songer DA, Schulte H. Venlafaxine for the treatment of chronic pain. Am J Psychiatry 1996;153(5):737.
  • Taylor K, Rowbotham MC. Venlafaxine hydrochloride and chronic pain. West J Med 1996;165(3):147–8.
  • Schulberg HC, Katon W, Simon GE, Rush AJ. Treating major depression in primary care practice: an update of the agency for health care policy and research practice guidelines. Arch Gen Psychiatry 1998;55(12):1121–7.
  • Nunes EV, Levin FR. Treatment of depression in patients with alcohol or other drug dependence: a meta-analysis. JAMA 2004;291(15):1887–96.
  • Frank E, Prien RF, Jarrett RB, Keller MB, Kupfer DJ, Lavori PW, et al. Conceptualization and rationale for consensus definition of terms in major depressive disorder: remission, recovery, relapse and recurrence. Arch Gen Psychiatry 1991;48(9):851–5.
  • Rush AJ, Kraemer HC, Sackeim HA, Fava M, Trivedi MH, Frank E, et al. Report by the acnp task force on response and remission in major depressive disorder. Neuropsychopharmacology 2006;31(9):1841–53.
  • Ruhe HG, Dekker JJ, Peen J, Holman R, de Jonghe F. Clinical use of the Hamilton depression rating scale: is increased efficiency possible? A post hoc comparison of Hamilton depression rating scale, Maier and Bech subscales, clinical global impression, and symptom chicklist-90 scores. Comp Psychiatry 2005;46(6):417–27.
  • Bech P, Gram LF, Dein E, Jacobsen O, Vitger J, Bolwig TG. Quantitative rating of depressive states. Acta Psychiatr Scand. 1975;51(3):161–70.
  • Gibbons RD, Clark DC, Kupfer DJ. Exactly what does the Hamilton depression rating scale measure? J Psychiatr Res 1993;27(3):259–73.
  • Maier W, Philipp M. Improving the assessment of severity of depressive states: a reduction of the Hamilton depression scale. Pharmacopsychiatry 1985;18(1):114–5.
  • Faries D, Herrera J, Rayamajhi J, DeBrota D, Demitrack M, Potter WZ. The responsiveness of the Hamilton depression rating scale. J Psychiat Res 2000;34(1):3–10.
  • Maier W, Heuser I, Philipp M, Frommberger U, Demuth W. Improving depression severity assessment – i. Reliability, internal validity and sensitivity to change of three observer depression scales. J Psychiat Res 1988;22(1):3–12.
  • Santen G, Gomeni R, Dnahof M, Della Pasqua O. Sensitivity of the individual items of the hamilton depression rating scale to response and its consequences for the assessment of efficacy. J Psychiat Res 2008;42(42):1000–9.
  • Bombardier CH, Fann JR, Tate DG, Richards JS, Wilson CS, Warren AM, et al. An exploration of modifiable risk factors for depression after spinal cord injury: which factors should we target? Arch Phys Med Rehabil 2012;93(5):775–81.
  • Williams JBW. A structured interview guide for the Hamilton depression rating scale. Arch Gen Psychiatry 1988;45(8):742–7.
  • First M, Gibbon M, Spitzer R, Williams J. User's guide for the structured clinical interview for DSM IV axis I disorders. New York: Biometrics Research Department, New York State Psychiatric Institute; 1996.
  • National Center for Complementary and Alternative Medicine. Data and safety monitoring of NCCAM-funded clinical research. In: Services USDoHaH, (ed.). Bethesda, MD: National Institutes of Health; 2012.
  • American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. text revision. Washington, DC: Author; 2000.
  • Zimmerman M, Posternak MA, Chelminski I. Symptom severity and exclusion from antidepressant efficacy trials. J Clin Psychopharmacol 2002;22(6):610–4.
  • Fava M. Diagnosis and definition of treatment-resistant depression. Biol Psychiatry 2003;53(8):649–59.
  • Nelson JC, Delucchi K, Schneider LS. Efficacy of second generation antidepressants in late-life depression: a meta-analysis of the evidence. Am J Geriatr Psychiatry 2008;16(7):558–67.
  • Tedeschini E, Fava M, Papakostas GI. Placebo-controlled, antidepressant clinical trials cannot be shortened to less than 4 weeks' duration: a pooled analysis of randomized clinical trials employing a diagnostic odds ratio-based approach. J Clin Psychiatry 2011;72(1):98–113.
  • Levkovitz Y, Tedeschini E, Papakostas GI. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials. J Clin Psychiatry 2011;72(4):509–14.
  • Gill D, Hatcher S. A systematic review of the treatment of depression with antidepressant drugs in patients who also have a physical illness. J Psychosom Res 1999;157(3):351–9.
  • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35(3):549–56.
  • National Spinal Cord Injury Statistical Center. Spinal cord injury facts and figures at a glance. Birmingham, AL: University of Alabama, Birmingham; 2012 [ 2012 November 21]; Available from: http://www.nscisc.uab.edu/PublicDocuments/fact_figures_docs/Facts 2012 Feb Final.pdf.
  • Raichle KA, Osborne TL, Jensen MP, Cardenas D. The reliability and validity of pain interference measures in persons with spinal cord injury. J Pain 2006;7(3):179–86.
  • National Spinal Cord Injury Statistical Center. The 2011 annual statistical report for the spinal cord injury model systems. Birmingham, AL: University of Alabama at Birmingham.
  • Whiteneck GG, Harrison-Felix CL, Mellick DC, Brooks CA, Charlifue SB, Gerhart KA. Quantifying environmental factors: a measure of physical, attitudinal, service, productivity, and policy barriers. Arch Phys Med Rehabil. 2004;85(8):1324–35.
  • Ottenbacher KJ. Clinically relevant designs for rehabilitation research: the idiographic model. Am J Phys Med Rehabil 1990;69(6):286–92.
  • Glasgow RE, Magid DJ, Beck A, Ritzwoller D, Estabrooks PA. Practical clinical trials for translating research to practice: design and measurement recommendations. Med Care 2005;43(6):551–7.
  • Horn SD, DeJong G, Deutscher D. Practice-based evidence research in rehabilitation: an alternative to randomized controlled trials and traditional observational studies. Arch Phys Med Rehabil 2012;93(8 Suppl):S127–37.
  • Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56–62.
  • Derogatis L, Rickels K, Uhlenhuth E, Covi L. The Hopkins Symptom Checklist: A measure of primary symptom dimensions. In: Pichot P, Olivier-Martin R, (eds). Psychological measurements in psychopharmacology. Modern Trends in Pharmacopsychiatry, Vol 7. Basel, Switzerland: Karger; 1974. p. 79–110.
  • Kroenke K, Spitzer R, Williams J. The PHQ-9: Validity of a brief depression symptom severity measure. J Gen Intern Med. 2001;16(9):606–13.
  • Guy W. ECDEU assessment manual for psychopharmacology —revised. Department of Health Education and Welfare, Public Health Service, Alcohol Drug Abuse and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs. Rockville, MD 1976. p. 218–22.
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: The GAD-7. Arch Intern Med. 2006 May 22;166(10):1092–7.
  • Weathers F, Litz B, Herman D, Huska J, Keane T. The PTSD checklist (PCL): Reliability, validity, and diagnostic utility. International Society for Traumatic Stress Studies; San Antonio, TX 1993.
  • Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV, 3rd, Hahn SR, et al. Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994 Dec 14;272(22):1749–56.
  • Andreasen NC, Endicott J, Spitzer RL, Winokur G. The family history method using diagnostic criteria. Reliability and validity. Arch Gen Psychiatry. 1977 Oct;34(10):1229–35.
  • Whiteneck GG, Charlifue SW, Gerhart KA, Overholser JD, Richardson GN. Quantifying handicap: A new measure of long-term rehabilitation outcomes. Arch Phys Med Rehabil. 1992 Jun;73(6):519–26.
  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71–5.
  • Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11( Suppl 3):89–95.
  • Ware J, Kosinski M, Keller S. Sf-12: How to score the SF-12 physical and mental health summary scales. 2nd ed. 1995.
  • Sherbourne CD, Stewart AL. The MOS Social Support Survey. Soc Sci Med. 1991;32(6):705–14.

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