Clinical Trial: Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Efficacy of SCH 420814 to Reduce the Frequency or Severity of Neuroleptic Induced Akathisia

Brief Summary: This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

• Part 1: Number of Participants With Akathisia [ Time Frame: Up to 13 days ]
  Incidence of akathisia is reported as the number of participants who experienced akathisia. Akathisia is defined as a score of 3 on the Barnes akathisia scale (BAS) for 3 consecutive intervals or an akathisia score (BAS) of ≥4 for any single day, or the use of a rescue medication within 13 days of initiating treatment with haloperidol and preladenant. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 - 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).
• Part 2: Number of Participants Who Were Treatment Failures [ Time Frame: Up to 14 days ]
  Incidence of treatment failure is reported as the number of participants who were treatment failures. A treatment failure is defined as the failure to achieve at least a 1 point reduction from baseline in BAS score at 24 to 26 hours following study treatment. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 - 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).

Original Primary Outcome: Part 1: Incidence of akathisia; Part 2: Incidence of treatment failure [ Time Frame: Day 13 ]

Current Secondary Outcome:

• Part 1: Mean Global Clinical Impression at Day 14 [ Time Frame: Day 14 of Part 1 ]
  Global clinical impression (GCI) was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).
• Part 1: Mean Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score at Day 14 [ Time Frame: Day 14 of Part 1 ]

  The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal).

  For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item).

• Part 2: Mean GCI at Day 14 [ Time Frame: Day 14 of Part 2 ]
  The GCI was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).
• Part 2: PANSS Total Score at Day 14 [ Time Frame: Day 14 of Part 2 ]
  The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item).

Original Secondary Outcome:

• Part 1 only: number of subjects that have a prevention failure (defined as the onset of akathisia) [ Time Frame: Day 13 ]
• Part 1: Global Clinical Impression, positive and negative symptom scale for schizophrenia (PANSS) Part 2: Global Clinical Impression, positive and negative symptom scale for schizophrenia (PANSS) [ Time Frame: Daily ]

Dates:
Date Received: May 27, 2008
Date Started: August 15, 2007
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017