Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine (LTTPANIC)
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|ClinicalTrials.gov Identifier: NCT02852577|
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Panic Disorder Agoraphobia||Drug: Clonazepam Drug: Paroxetine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term, Open, Naturalistic, Randomized Clinical Trial With Clonazepam and Paroxetine in Panic Disorder With or Without Agoraphobia|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: Clonazepam
Treatment with 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.
Active Comparator: Paroxetine
Treatment with 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.
- Clinical Global Impression Severity scores at 8 weeks [ Time Frame: 8 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852577
|Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro|
|Rio de Janeiro, Brazil, 22290140|
|Principal Investigator:||Rafael C Freire, MD, PhD||Universidade Federal do Rio de Janeiro|