Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder

A Randomized, Controlled Trial on the Effects of Paroxetine Versus Placebo in Combination With Aerobic Exercise or Relaxation Training in the Treatment of Panic Disorder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00540098

Acronym

Exparox

Enrollment

Registered

2007-10-05

Start date

2001-09-30

Completion date

2005-06-30

Last updated

2007-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic Disorder

Keywords

panic disorder, pharmacotherapy, non-pharmacological treatment, SSRI, paroxetine, exercise

Brief summary

Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination with regular aerobic exercise (running) or regular relaxation training in the treatment of panic disorder.

Detailed description

In continuation of prior work from our group (Broocks A, Bandelow B, Pekrun G, et al. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry 1998; 155(5):603-9.) it is the purpose of this trial to test the assumed superiority of a combined therapy of paroxetine and aerobic exercise compared to placebo or unspecific relaxation training in panic disorder. Participants were randomized to a 10 week treatment protocol of paroxetine 40 mg daily or placebo in combination with regular exercise or regular relaxation after having given informed consent and screening of in- and exclusion criteria.

Interventions

DRUGparoxetine + aerobic exercise

paroxetine, 40 mg once daily + regular aerobic exercise

DRUGParoxetine + relaxation

paroxetine, 40 mg once daily + regular relaxation training

DRUGPlacebo + aerobic exercise

placebo pill once daily + regular aerobic exercise

DRUGPlacebo + relaxation

placebo pill once daily + regular relaxation training

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Panic disorder with or without agoraphobia due to DSM-IV * Written informed consent * Score of 17 or more on the P&A scale * Score on the CGI of 4 or more (markedly ill)

Exclusion criteria

* Pregnancy, lactating or insufficient contraception (pearl index \>1) * Other psychiatric disorders such as psychoses, addictive disorders, dementia, etc. * Clinically relevant abnormalities in physical examination or laboratory results * Prior major depression or bipolar disorder * Suicidality * psychotropic medication other than promethazine * current psychological treatment * unable to perform regular aerobic exercise

Design outcomes

Primary

Measure	Time frame
Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)	Baseline to endpoint (10 weeks)
Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)	Baseline to endpoint (10 weeks)

Secondary

Measure	Time frame
Symptom severity due to Hamilton Anxiety Scale (HAMA)	Baseline to endpoint (10 weeks)
Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)	Baseline to endpoint (10 weeks)
Response and remission analysis between groups	LOCF-analysis

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026