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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00438971
• Date of registration: 20/02/2007
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder
• Scientific title: The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder
• Date of first enrolment: August 2006
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00438971
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Mark H Pollack, M.D.
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Panic Disorder

Intervention(s)

Drug: Duloxetine

Primary Outcome(s)

Panic Disorder Severity Scale (PDSS) [Time Frame: 8 weeks]

Secondary Outcome(s)

Clinical Global Impression of Severity Scale (CGI-S) [Time Frame: 8 weeks]

Panic Attack Scale (PAS) [Time Frame: 8 weeks]

Secondary ID(s)

2006-P-000263

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company

Results

• Results available: Yes
• Date Posted: 19/12/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00438971