Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine

Last updated: July 28, 2016
Sponsor: Universidade Federal do Rio de Janeiro
Overall Status: Completed

Phase

4

Condition

Anxiety Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT02852577
0003.0.249.000-09
  • Ages 18-60
  • All Genders

Study Summary

The purpose of this study was to determine whether clonazepam and paroxetine are effective in the treatment of panic disorder. Efficacy was evaluated in short-term, long-term and post-treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of panic disorder, with or without agoraphobia according to the Diagnosticand Statistical Manual of Mental Disorders, Fourth Edition, text revision (DSM-IV-TR)criteria, as determined by a structured clinical interview.

  • At least two panic attacks in the week preceding their inclusion in the study.

Exclusion

Exclusion Criteria:

  • Patients unable or unwilling to provide written informed consent.

  • Did not complete all the evaluations before study initiation.

  • Had comorbidities that could affect clinical evaluation including drug abuse,neurological disorders, or severe personality disorder.

Study Design

Total Participants: 120
Study Start date:
January 01, 2000
Estimated Completion Date:
August 31, 2012

Study Description

The current study consisted of three steps. The first step was a naturalistic, prospective, randomized, open clinical trial with clonazepam and paroxetine. Subjects received either flexible dose clonazepam (0.5 - 2 mg/day) or paroxetine (10 - 40 mg/day), in monotherapy for eight weeks. In the second step, those who responded to monotherapy in the short-term study continued with the same drug and dose. Partial responders or non-responders were invited to receive combined pharmacological treatment with clonazepam and paroxetine. Patients received the maximum tolerated doses of clonazepam and paroxetine. The doses were flexible, ranging from 0.5 to 2 mg/day for clonazepam and from 10 to 40 mg/day of paroxetine. All patients were treated for 34 months in the second step. Patients who completed the second step and were in remission were included in the third step. For a period of four months all medications were tapered off. These patients were followed for 6 years with evaluations once a year. Those who relapsed were treated on a naturalistic basis, with drugs or psychotherapy.

This study was conducted in accordance with the ethical principles established by the Declaration of Helsinki and the Brazilian National Ethics Committee (Conselho Nacional de Ética em Pesquisa - CONEP) guidelines. The local Ethics Committee approved the study protocol. Written informed consent was obtained from all patients.

Connect with a study center

  • Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

    Rio de Janeiro, 22290140
    Brazil

    Site Not Available

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