Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine

Phase 4

Completed

• Conditions: Agoraphobia; Panic Disorder
• Interventions: Drug: Clonazepam; Drug: Paroxetine

• Registration Number: NCT02852577
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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 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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-28
• Last Update Submitted: 2016-07-28
• Study First Posted: 2016-08-02
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Diagnosis of panic disorder, with or without agoraphobia according to the Diagnostic and 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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonazepam	Clonazepam	Treatment with clonazepam
Paroxetine	Paroxetine	Treatment with paroxetine

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression Severity scores at 8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression Severity scores at 9 years	9 years
Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 36 months	Baseline, 36 months
Clinical Global Impression Severity scores at 36 months	36 months
Clinical Global Impression Severity scores at 4 years	4 years
Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 8 weeks	Baseline, 8 weeks

Trial Locations

Locations (1)

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil