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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonazepam | Active Comparator | Treatment with clonazepam |
|
| Paroxetine | Active Comparator | Treatment with paroxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonazepam | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Severity scores at 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Severity scores at 36 months | 36 months | |
| Clinical Global Impression Severity scores at 4 years | 4 years | |
| Clinical Global Impression Severity scores at 9 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael C Freire, MD, PhD | Universidade Federal do Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro | Rio de Janeiro | Rio de Janeiro | 22290140 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21344132 | Result | Nardi AE, Valenca AM, Freire RC, Mochcovitch MD, Amrein R, Sardinha A, Levitan MN, Nascimento I, de-Melo-Neto VL, King AL, de O E Silva AC, Veras AB, Dias GP, Soares-Filho GL, da Costa RT, Mezzasalma MA, de Carvalho MR, de Cerqueira AC, Hallak JE, Crippa JA, Versiani M. Psychopharmacotherapy of panic disorder: 8-week randomized trial with clonazepam and paroxetine. Braz J Med Biol Res. 2011 Apr;44(4):366-73. doi: 10.1590/s0100-879x2011007500020. Epub 2011 Feb 18. | |
| 21364347 |
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| D000379 | Agoraphobia |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D002998 | Clonazepam |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Paroxetine | Drug | 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. |
|
| 9 years |
| Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 8 weeks | Baseline, 8 weeks |
| Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 36 months | Baseline, 36 months |
| Result |
| Nardi AE, Valenca AM, Freire RC, Amrein R, Sardinha A, Levitan MN, Nascimento I, de-Melo-Neto VL, King AL, de O e Silva AC, Veras AB, Dias GP, Soares-Filho GL, da Costa RT, Mezzasalma MA, de Carvalho MR, de Cerqueira AC, Hallak JE, Crippa JA, Versiani M. Randomized, open naturalistic, acute treatment of panic disorder with clonazepam or paroxetine. J Clin Psychopharmacol. 2011 Apr;31(2):259-61. doi: 10.1097/JCP.0b013e318210b4ee. No abstract available. |
| 22198456 | Result | Nardi AE, Freire RC, Mochcovitch MD, Amrein R, Levitan MN, King AL, Valenca AM, Veras AB, Paes F, Sardinha A, Nascimento I, de-Melo-Neto VL, Dias GP, E Silva AC, Soares-Filho GL, da Costa RT, Mezzasalma MA, de Carvalho MR, de Cerqueira AC, Hallak JE, Crippa JA, Versiani M. A randomized, naturalistic, parallel-group study for the long-term treatment of panic disorder with clonazepam or paroxetine. J Clin Psychopharmacol. 2012 Feb;32(1):120-6. doi: 10.1097/JCP.0b013e31823fe4bd. |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |