Study: NCT01127607

Adverse event: Buccal Lingual Movements
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS):Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 2 affected / 13 at risk

Adverse event: picking at skin
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 2 affected / 13 at risk

Adverse event: anxious/jittery
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 2 affected / 13 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 1 affected / 13 at risk

Adverse event: appetite decrease
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 2 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 4 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Endocrine disorders
Notes: This event was spontaneously reported. It is not listed on the PSERS.refers to participants report of experiencing decreased salivation or a sense of "dry mouth"
Frequency: 1 affected / 13 at risk

Adverse event: anxious/jittery
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 1 affected / 13 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 13 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 1 affected / 13 at risk

Adverse event: appetite decrease
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 13 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: This event was spontaneously reported. It is not listed on the PSERS.
Frequency: 1 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Endocrine disorders
Notes: This event was spontaneously reported. It is not listed on the PSERS.refers to participants report of experiencing decreased salivation or a sense of "dry mouth"
Frequency: 3 affected / 13 at risk

Adverse event: Buccal Lingual Movements
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS):Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 7 affected / 36 at risk

Adverse event: picking at skin
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 4 affected / 36 at risk

Adverse event: anxious/jittery
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 13 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 6 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 13 affected / 36 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 10 affected / 36 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 5 affected / 36 at risk

Adverse event: appetite decrease
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 19 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 11 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Endocrine disorders
Notes: This event was spontaneously reported. It is not listed on the PSERS.refers to participants report of experiencing decreased salivation or a sense of "dry mouth"
Frequency: 11 affected / 36 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 6 affected / 36 at risk

Adverse event: socially withdrawn
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 36 at risk

Adverse event: Buccal Lingual Movements
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS):Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 6 affected / 21 at risk

Adverse event: picking at skin
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 21 at risk

Adverse event: anxious/jittery
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 6 affected / 21 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 5 affected / 21 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 4 affected / 21 at risk

Adverse event: appetite decrease
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 14 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 7 affected / 21 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Endocrine disorders
Notes: This event was spontaneously reported. It is not listed on the PSERS.refers to participants report of experiencing decreased salivation or a sense of "dry mouth"
Frequency: 8 affected / 21 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 1 affected / 21 at risk

Adverse event: Buccal Lingual Movements
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS):Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 4 affected / 17 at risk

Adverse event: picking at skin
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 1 affected / 17 at risk

Adverse event: anxious/jittery
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 3 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 2 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 5 affected / 17 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 4 affected / 17 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 2 affected / 17 at risk

Adverse event: appetite decrease
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 12 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 6 affected / 17 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Endocrine disorders
Notes: This event was spontaneously reported. It is not listed on the PSERS.refers to participants report of experiencing decreased salivation or a sense of "dry mouth"
Frequency: 12 affected / 17 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 5 affected / 17 at risk

Adverse event: Tic
Serious: no
Organ System: Nervous system disorders
Notes: Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
Frequency: 2 affected / 17 at risk