NCT02852577

Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Panic Disorder
• Agoraphobia

Interventions

Type	Name	Description
DRUG	Clonazepam	Administration of clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 36 months. If no remission after 8 weeks augmentation with paroxetine once a day, flexible dose (10 - 40 mg/day), for 34 months.
DRUG	Paroxetine	Administration of paroxetine once a day, flexible dose (10 - 40 mg/day), for 36 months. If no remission after 8 weeks augmentation with clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 34 months.

Timeline

• Start date: 2000-01-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2016-08-02
• Last updated: 2016-08-02

Locations

1 site across 1 country: Brazil