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Chronic Depression: Medication

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Chronic Depression: Medication ORIGINAL ARTICLE Chronic Depression Medication (Nefazodone) or Psychotherapy (CBASP) Is Effective When the Other Is Not Alan F. Schatzberg, MD; A. John Rush, MD; Bruce A. Arnow, PhD; Phillip L. C. Banks, MS; Janice A. Blalock, PhD; Frances E. Borian, RN; Robert Howland, MD; Daniel N. Klein, PhD; James H. Kocsis, MD; Susan G. Kornstein, MD; Rachel Manber, PhD; John C. Markowitz, MD; Ivan Miller, PhD; Philip T. Ninan, MD; Barbara O. Rothbaum, PhD; Michael E. Thase, MD; Madhukar H. Trivedi, MD; Martin B. Keller, MD Context: Although various strategies are available to man- Main Outcome Measures: The 24-item Hamilton Rat- age nonresponders to an initial treatment for depres- ing Scale for Depression, administered by raters blinded sion, no controlled trials address the utility of switching to treatment, the Clinician Global Impressions–Severity from an antidepressant medication to psychotherapy or scale, and the 30-item Inventory for Depressive Symp- vice versa. tomatology–Self-Report. Objective: To compare the responses of chronically de- Results: Analysis of the intent-to-treat sample revealed pressed nonresponders to 12 weeks of treatment with that both the switch from nefazodone to CBASP and the either nefazodone or cognitive behavioral analysis sys- switch from from CBASP to nefazodone resulted in clini- tem of psychotherapy (CBASP) who were crossed over cally and statistically significant improvements in symp- to the alternate treatment (nefazodone, n=79; CBASP, toms. Neither the rates of response nor the rates of re- n=61). mission were significantly different when the groups of completers were compared. However, the switch to CBASP Design: Crossover trial. following nefazodone therapy was associated with sig- nificantly less attrition due to adverse events, which may Setting: Twelve academic outpatient psychiatric centers. explain the higher intent-to-treat response rate among Patients: There were 140 outpatients with chronic ma- those crossed over to CBASP (57% vs 42%). jor depressive disorder; 92 (65.7%) were female, 126 (90.0%) were white, and the mean age was 43.1 years. Conclusions: Among chronically depressed individu- Thirty participants dropped out of the study prema- als, CBASP appears to be efficacious for nonresponders turely, 22 in the nefazodone group and 8 in the CBASP to nefazodone, and nefazodone appears to be effective group. for CBASP nonresponders. A switch from an antidepres- sant medication to psychotherapy or vice versa appears Interventions: Treatment lasted 12 weeks. The dos- to be useful for nonresponders to the initial treatment. age of nefazodone was 100 to 600 mg/d; CBASP was pro- vided twice weekly during weeks 1 through 4 and weekly thereafter. Arch Gen Psychiatry. 2005;62:513-520 SUBSTANTIAL PROPORTION nicians as to the preferable next step.3-5 Im- of patients treated for de- portantly, many depressed patients ini- pression do not respond to tially receive psychotherapy alone. the initial trial of either an Surprisingly few studies6 have evaluated the antidepressant medica- role of medication following nonresponse tion or depression-targeted psycho- to psychotherapy.7 None has evaluated the A1 therapy. This so-called stage I antidepres- efficacy of psychotherapy following non- sant resistance2,3 is one of several degrees response to medication. Surprisingly few of resistance defined by prior treatment his- controlled switch studies are available even tory. Numerous treatment options are avail- for medication-to-medication switches.7,8 able in such situations, including switch- This report provides the first prospective ing medication type or class, augmenting controlled trial evidence, using blinded rater or combining medications, and switching methodology, to examine switching from Author Affiliations are listed at to or augmenting with psychotherapy. nefazodone therapy to psychotherapy (spe- the end of this article. There are few controlled data to guide cli- cifically, cognitive behavioral analysis sys- (REPRINTED) ARCH GEN PSYCHIATRY/ VOL 62, MAY 2005 WWW.ARCHGENPSYCHIATRY.COM 513 ©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 minimally adequate trial of nefazodone (ie, at least 4 weeks at Ն300 Assessed for Eligibility mg/d) were not eligible. Patients could not have been treated with (N = 1035) benzodiazepines within 2 weeks, fluoxetine or monoamine oxi- dase inhibitors within 4 weeks, electroconvulsive therapy within Randomized Not Randomized (n = 354) 6 months, or depot neuroleptics within 6 months. No psycho- (n = 681) • Did Not Meet Inclusion therapy outside the study protocol was permitted. Criteria (n = 235) • Withdrew Consent (n = 47) INITIAL ACUTE-PHASE TREATMENT TRIAL • Other Reasons (n = 72) Participants were recruited via advertisements in newspapers, Nefazodone CBASP Combination radio, and printed flyers as well as through physician refer- (n = 226) (n = 228) (n = 227) rals. After providing written informed consent, subjects un- derwent a complete medical history interview, physical exami- Nonresponders Nonresponders nation, electrocardiogram, and laboratory screening test battery (n = 73) (n = 83) to confirm medical eligibility. No nonprotocol psychotropic medications were allowed during the study, including anxio- Declined Entered CBASP Entered Declined lytics and sedative hypnotics. Patients agreed to randomiza- Crossover (Intention-to- Nefazodone Crossover tion to CBASP, nefazodone, or the combination for this 12- (n = 12) Treat Sample) (Intention-to- (n = 4) week acute-phase trial (Figure 1). (n = 61) Treat Sample) (n = 79) Patients randomized to nefazodone monotherapy or com- bined nefazodone therapy and CBASP received open-label treat- ment with oral nefazodone. Those patients receiving nefaz- Dropped Completers Completers Dropped odone, either with or without CBASP, received an initial daily Out (n = 53) (n = 57) Out (n = 8) (n = 22) dose of 200 mg (100 mg twice a day), which was increased to 300 mg/d during the second week. Thereafter, when indi- cated, the dose was increased in increments of 100 mg/d to a Figure 1. Randomization and disposition. maximum of 600 mg/d. To remain in the study, patients were required to take a minimum of 300 mg/d by week 3. Patients tem of psychotherapy [CBASP])9 or switching from CBASP noncompliant with prescribed dosing were dropped from the to nefazodone therapy following completion with nonre- study. At the end of the initial acute-phase trial, the overall fi- sponse to a 12-week trial of the alternative treatment. nal average daily dosage of nefazodone was 461.0 mg/d (SD, 143.3 mg/d). Psychopharmacology visits were conducted ac- cording to a manual13 for clinical management (eg, review of METHODS symptoms, adverse events, illnesses, and concomitant medi- cations) and were limited to 15 to 20 minutes. SUBJECTS Cognitive behavioral analysis system of psychotherapy, which was developed to address the specific challenges of treating in- This protocol was part of a multiphase collaborative research pro- dividuals with chronic depression, incorporates both cogni- gram studying chronic depressive disorders (see Keller et al10 for tive behavioral and interpersonal features.9 Treatment was con- a full description of study design, rationale, and methods). The ducted according to a manual14 specifying sessions twice weekly institutional review boards at all 12 sites approved the study. during weeks 1 through 4 and weekly thereafter until week 12. Briefly, outpatients 18 to 75 years of age who were in a current Sessions could be held twice weekly during weeks 5 through 8 major depressive episode were eligible to enroll at one of 12 cen- if the patient was having trouble mastering situational analy- ters if they met the DSM-IV criteria for chronic major depres- sis, the core procedure in CBASP.9 Patients who attended fewer sive disorder (ie, current major depressive episode Ն2 years in than 13 sessions or missed 3 consecutive sessions were dropped duration), “double depression” (ie, a current major depressive from the study. The overall mean number of total CBASP ses- episode superimposed on antecedent dysthymic disorder), or re- sions for the intent-to-treat acute-phase sample was 16 (SD, 5.4). current major depressive disorder with incomplete interepi- Psychotherapists had either (1) an MD or PhD degree along sode recovery. Additionally, patients had to have a score of 20 with at least 2 years of post-training experience or (2) an MSW or higher on the 24-item Hamilton Rating Scale for Depression degree along with at least 5 years of post-degree experience. (HRS-D24) both at screening and following a 2-week drug-free All psychotherapists attended a 2-day training workshop and period at baseline prior to treatment initiation. met the criteria for mastery of CBASP treatment procedures on The Structured Clinical Interview for DSM-IV Axis I Disor- 2 pilot training cases, as assessed by videotape-based adher- ders11 and an abbreviated version of the Structured Clinical In- ence rating, before they were allowed to see study patients. Ad- terview for DSM-IV Personality Disorders12 were used to estab- herence monitoring to the CBASP protocol took place through- lish the intake diagnoses. Patients with organic mental syndromes; out the study. All study CBASP sessions were videotaped. The bipolar disorder or cyclothymia; schizophrenia or other psy- CBASP supervisors at each site conducted weekly adherence chotic disorders; obsessive-compulsive disorder; or schizotypal, monitoring
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