Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00031317
• Date of registration: 28/02/2002
• Prospective Registration: No
• Primary sponsor: National Institute of Mental Health (NIMH)
• Public title: Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression
• Scientific title: Combined Treatment With A Benzodiazepine (Clonazepam) And A Selective Serotonin Reuptake Inhibitor (Paroxetine) For Rapid Treatment Of Panic Disorder With Depression
• Date of first enrolment: February 2002
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00031317
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

Patients with a primary diagnosis of Panic Disorder without Agoraphobia or Panic Disorder
with Agoraphobia according to DSM-IV criteria, and co-morbid major depressive disorder are
eligible. Patients are required to have a weekly panic attack frequency of greater than or
equal to 1/ week in the month prior to intake or a CGI score greater than 4 in the week
prior to randomization. Patients with co-morbid major depressive disorder will be included
provided that the onset of PD was earlier than the onset of the depressive disorder. The
presence of co-morbid depression will be determined by using DSM-IV criteria for major
depressive disorder, and HDRS scores will be in the moderately-to-severely depressed range
(greater than 15).

Subjects will be at least 18 years old. Those above age 65 years must be able to tolerate
paroxetine starting dose of at least 20 mg daily and be without hepatic or renal
impairment.

Male and female subjects will be included.

The patient must have given written informed consent prior to any study procedures.

In addition, eligible patients must be in good physical health as confirmed by a complete
physical exam (including normal vital signs), electrocardiogram, neurological exam, and
routine laboratory tests of blood and urine.

Patients will be drug free for at least 7 days when starting with the study medication. We
will study both, untreated, symptomatic patients, and patients who did not respond to
their pervious psychopharmacological treatment. The unsuccessful medication will be
tapered off, and a medication-free period of 7 days will be established.

EXCLUSION CRITERIA:

Patients with any serious or unstable medical disorder or condition that would preclude
the administration of paroxetine or clonazepam (e.g. epilepsy, severe head injury,
meningitis, allergic to either drug).

Patients who would be unable to comply with study procedures or assessments.

Patients who meet DSM-IV lifetime criteria for benzodiazepine abuse or dependence.

Patients who are on other psychotropic drugs must have discontinued them for at least 1
week prior to randomization. Patients are ineligible who experience any current signs of
symptoms of drug withdrawal during taper of unsuccessful medication.

Patients who are currently at high risk for homicide or suicide.

Patients who had previously failed an adequate trial of paroxetine or clonazepam.

Women of childbearing potential who are not practicing a clinically accepted method of
contraception or who have a positive pregnancy test or who are lactating.

Patients who are currently treated with fluoxetine.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Panic Disorder

Intervention(s)

Drug: Paroxetine

Drug: Clozapine

Secondary ID(s)

02-M-0136

020136

Source(s) of Monetary Support

Please refer to primary and secondary sponsors