Clinical Trial: Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Long-term, Open, Naturalistic, Randomized Clinical Trial With Clonazepam and Paroxetine in Panic Disorder With or Without Agoraphobia

Brief 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.

Detailed Summary:

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.


Sponsor: Universidade Federal do Rio de Janeiro

Current Primary Outcome: Clinical Global Impression Severity scores at 8 weeks [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Global Impression Severity scores at 36 months [ Time Frame: 36 months ]
  • Clinical Global Impression Severity scores at 4 years [ Time Frame: 4 years ]
  • Clinical Global Impression Severity scores at 9 years [ Time Frame: 9 years ]
  • Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  • Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 36 months [ Time Frame: Baseline, 36 months ]


Original Secondary Outcome: Same as current

Information By: Universidade Federal do Rio de Janeiro

Dates:
Date Received: July 21, 2016
Date Started: January 2000
Date Completion:
Last Updated: July 28, 2016
Last Verified: July 2016