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Trial · NCT00658008

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
8 weeks
PrimaryThe safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study8 weeks
SecondaryWorsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)8 weeks
SecondaryResponse rate on the patient-rated PGI-C at week 88 weeks
SecondaryChange from baseline to week 8 on the Sheehan Disability Scale subscales8 weeks
SecondaryChange from baseline in the somatic subscale score of the HAM-A (items 7 - 13)8 weeks
SecondaryResponse rate on the HAM-A at week 1 and week 88 weeks
SecondaryResponse rate on the clinician-rated CGI-I ate week 1 and week 88 weeks
SecondaryChange from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 88 weeks
SecondaryChange from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II1 week
SecondaryChange from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II8 weeks
SecondaryChange from baseline in the HAM-A total score at weeks 1, 2, 4, and 66 weeks
SecondaryChange from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 88 weeks
SecondaryChange from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales8 weeks
SecondaryRemission rate based on the HAM A at Week 88 weeks
SecondaryChange from baseline in CGI-S at week 88 weeks
SecondaryChange from baseline to week 8 in the QLesQ General Activity Score8 weeks
Secondary
The "Week 1 Sustained Responder" rate based on the HAM A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM A total score at Week 1 that is sustained until the Week 8 visit)
1 week
SecondaryChange from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)8 weeks
SecondaryChange from baseline to week 8 on the Sheehan Disability Scale (SDS) total score8 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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