The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder

NCT00438971 | Completed Phase 4 Results

• 1 other identifier: 2006-P-000263
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether duloxetine is effective in the treatment of panic disorder.

Conditions

Panic Disorder

Keywords

Panic Disorder; Anxiety Disorder; Duloxetine

Outcome Measures

Primary Outcomes (1)

• Panic Disorder Severity Scale (PDSS)

  The PDSS contains seven items assessing multiple dimensions of panic disorder severity, including (a) frequency of panic attacks, (b) distress during panic attacks, (c) anticipatory anxiety, (d) agoraphobic fear and avoidance, (e) interoceptive fear and avoidance, (f) impairment of work functioning, and (g) impairment of social functioning. The PDSS ranges from 0 to 28, with higher ratings reflecting greater degrees of symptom severity.

  8 weeks

Secondary Outcomes (2)

• Clinical Global Impression of Severity Scale (CGI-S)

  8 weeks

• Panic Attack Scale (PAS)

  8 weeks

Other Outcomes (5)

• Montgomery Asberg Depression Rating Scale (MADRS)

  8 weeks

• Beck Anxiety Inventory (BAI)

  8 weeks

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  8 weeks

Study Arms (1)

Duloxetine

EXPERIMENTAL

Drug: Duloxetine

Interventions

Duloxetine DRUG

Treatment will be initiated at 30mg/day in the first week (week 0), and then increased to 60mg/day at week 1, with the option to increase to 90mg at week 4, and 120mg at week 6.

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients, age 18-75.
• Diagnosis of Panic Disorder with or without Agoraphobia by DSM-IV criteria
• MGH Panic Clinical Global Impression of Severity score Score equal to or greater than 4
• Patients with current major depressive disorder will be allowed if the panic disorder is primary (as determined on interview by clinician and patient), and the baseline MADRS score is less than or equal to 20
• Willingness and ability to comply with the requirements of the study protocol.

You may not qualify if:

• Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
• Patients with current or history of posttraumatic stress disorder, obsessive compulsive disorder, bipolar disorder, schizophrenia or other psychotic conditions.
• Patients on other psychoactive medication, including MAOIs, and those with the potential need to use an MAOI during the study or within 5 day of discontinuation of study drug will be excluded. Participants must have discontinued MAOI use at least 14 days prior study baseline. Patients must discontinue regular benzodiazepine or other non-MAOI antidepressant therapy at least one week (5 weeks for fluoxetine) prior to baseline. Concomitant beta-blockers are proscribed unless prescribed for a medical indication (e.g., hypertension, at a stable daily dose for \> 1 month).
• Patients with a history of alcohol or substance abuse or dependence within the last twelve months, significant alcohol dependence, or a positive toxicology screen consistent with abuse at baseline.
• Patients with significant or unstable neurological or medical disorders or instability for which hospitalization may be likely within the next year. In particular, patients with end-stage renal disease (requiring dialysis) or severe renal impairment, or hepatic insufficiency (defined as twice normal on LFTs as follows: SGPT \>110 u/L or SGOT \>80 u/L) will be excluded.
• Patients with uncontrolled narrow-angle glaucoma will be excluded.
• Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood, were isolated, and did not recur in adulthood.
• Severe personality disorders likely to interfere with study participation.
• Ongoing psychotherapy directed toward the treatment of the panic disorder or agoraphobia. Prohibited psychotherapy includes cognitive behavioral therapy or psychodynamic therapy that focuses on exploring specific, dynamic causes of the panic or phobic symptoms and provides skills for their management, or any of the active ingredients of these psychotherapies. General supportive individual, couples, or family therapy greater than 2 months duration is acceptable.
• History of hypersensitivity or prior non-response or intolerance of duloxetine.
• Patients who have failed 4 or more medication trials of at least 4 weeks at adequate dose (e.g. paroxetine 20mg or equivalent). Treatment failure is here defined as clinician judgment based on assessment of patient history of prior treatment of minimal or no reduction in panic attacks, anticipatory anxiety or avoidance during a specific, medication trial.
• Patients with significant suicidal ideation (MADRS item 10 score \> 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

The Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

• Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.

  PMID: 8279933 BACKGROUND

• Marzol PC, Pollack MH. New developments in panic disorder. Curr Psychiatry Rep. 2000 Aug;2(4):353-7. doi: 10.1007/s11920-000-0081-8.

  PMID: 11122981 BACKGROUND

• Katon W, Hart R, Montano B. The effect of panic disorder in the managed care setting. Manag Care Interface. 1997 Nov;10(11):88-94, 98.

  PMID: 10174760 BACKGROUND

• Sartorius N, Ustun TB, Costa e Silva JA, Goldberg D, Lecrubier Y, Ormel J, Von Korff M, Wittchen HU. An international study of psychological problems in primary care. Preliminary report from the World Health Organization Collaborative Project on 'Psychological Problems in General Health Care'. Arch Gen Psychiatry. 1993 Oct;50(10):819-24. doi: 10.1001/archpsyc.1993.01820220075008.

  PMID: 8215805 BACKGROUND

• Rubin HC, Rapaport MH, Levine B, Gladsjo JK, Rabin A, Auerbach M, Judd LL, Kaplan R. Quality of well being in panic disorder: the assessment of psychiatric and general disability. J Affect Disord. 2000 Jan-Mar;57(1-3):217-21. doi: 10.1016/s0165-0327(99)00030-0.

  PMID: 10708834 BACKGROUND

• Cramer V, Torgersen S, Kringlen E. Quality of life and anxiety disorders: a population study. J Nerv Ment Dis. 2005 Mar;193(3):196-202. doi: 10.1097/01.nmd.0000154836.22687.13.

  PMID: 15729110 BACKGROUND

• Pollack MH. The pharmacotherapy of panic disorder. J Clin Psychiatry. 2005;66 Suppl 4:23-7.

  PMID: 15842184 BACKGROUND

• Pollack MH, Meoni P, Otto MW, Simon N, Hackett D. Predictors of outcome following venlafaxine extended-release treatment of DSM-IV generalized anxiety disorder: a pooled analysis of short- and long-term studies. J Clin Psychopharmacol. 2003 Jun;23(3):250-9. doi: 10.1097/01.jcp.0000084025.22282.84.

  PMID: 12826987 BACKGROUND

• Goldstein DJ, Lu Y, Detke MJ, Wiltse C, Mallinckrodt C, Demitrack MA. Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine. J Clin Psychopharmacol. 2004 Aug;24(4):389-99. doi: 10.1097/01.jcp.0000132448.65972.d9.

  PMID: 15232330 BACKGROUND

• Simon NM, Kaufman RE, Hoge EA, Worthington JJ, Herlands NN, Owens ME, Pollack MH. Open-label support for duloxetine for the treatment of panic disorder. CNS Neurosci Ther. 2009 Winter;15(1):19-23. doi: 10.1111/j.1755-5949.2008.00076.x.

  PMID: 19228176 RESULT

MeSH Terms

Conditions

Panic Disorder; Anxiety Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Mark Pollack
• Organization: Rush University

mark_pollack@rush.edu

312-942-5372

Study Officials

• Mark H Pollack, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: August 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 27, 2016
• Results First Posted: December 19, 2013

Record last verified: 2016-03

Locations

US (1)