GSK‐29060/525.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: Panic disorder; no further details provided Method of diagnosis: Not stated Age: for paroxetine, M = 37.12 (SD = 9.92); for clomipramine, M = 40.13 (SD = 11.34) Sex: for paroxetine, 14 women, 23 men, 1 unknown; for clomipramine 17 women, 14 men Location: China; setting unclear Co‐morbidities: patients with current major depression were excluded. No other co‐morbidities mentioned Rescue medication: Not stated |
|
Interventions |
Participants were randomly assigned to either: (1) paroxetine arm (n = 38) Duration: 10 weeks Treatment Protocol: flexible dosage; range = 10 ‐ 50 mg, M and SD not provided (2) clomipramine arm (n = 35) Duration: 10 weeks Treatment Protocol: flexible dosage; range = 50 ‐ 100 mg, M and SD not provided |
|
Outcomes |
Time points for assessment: baseline, endpoint (10 weeks) Outcomes: 1. mean change from baseline in the number of full panic attacks 2. Hamilton Rating Scale for Anxiety (HAMA) 3. Panic Associated Symptoms Scale 4. Clinical Global Impression Severity of Illness Score (CGI‐S) 5. Patient Global Evaluation (PGE) |
|
Notes |
Date of study: September 1998 to September 1999 Funding source: GSK Declarations of interest among the primary researchers: Not stated. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blind". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blind". No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "ITT population consisted of all subjects who received treatment and have one post treatment evaluation". |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | Sponsored by GSK; the role of the funder in planning, conducting and writing the study is not discussed. |