Trial Outcomes & Findings for Drug Therapy to Treat Minor Depression (NCT NCT00048815)

Last Updated: 2018-05-11

Results Overview

We expect that subjects with minor depression treated for 12 weeks with St. John's Wort or citalopram will have significantly greater reduction in depressive symptom severity than those treated with placebo. This will be measured by blind ratings on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) which has a total score range from 0 to 84 with 0 being not depressed at all and 84 being the most depressed. The change will be calculated by subtracting the Week 12 score from the Baseline score.

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

Change from Baseline to Week 12

Results posted on

2018-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Citalopram Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.	St. John's Wort Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.	Placebo Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
Overall Study STARTED	24	26	23
Overall Study COMPLETED	18	22	19
Overall Study NOT COMPLETED	6	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug Therapy to Treat Minor Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Citalopram n=24 Participants Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.	St. John's Wort n=26 Participants Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.	Placebo n=23 Participants Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.	Total n=73 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 12.5 • n=5 Participants	42.2 years STANDARD_DEVIATION 14.1 • n=7 Participants	51.4 years STANDARD_DEVIATION 16.6 • n=5 Participants	48.1 years STANDARD_DEVIATION 15.0 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	26 Participants n=7 Participants	22 Participants n=5 Participants	70 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	24 participants n=5 Participants	26 participants n=7 Participants	23 participants n=5 Participants	73 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from Baseline to Week 12

Outcome measures

Outcome measures
Measure	Citalopram n=24 Participants Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.	St. John's Wort n=26 Participants Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.	Placebo n=23 Participants Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)	-11.47 units on a scale Standard Error 1.36	-9.35 units on a scale Standard Error 1.23	-10.49 units on a scale Standard Error 1.37

PRIMARY outcome

Timeframe: Change from Baseline to Week 12

We expect that subjects treated for Minor Depression for 12 weeks with either St. John's Wort or citalopram will have similar safety profiles to subjects treated with placebo, and will not differ by more than 20% in rates of adverse side effects (e.g., nausea, headache, insomnia, hypersomnia, diarrhea) from subjects treated with placebo. This was measured by the number of adverse events (physical symptoms) emerging or worsening during 12 weeks of treatment.

Outcome measures

Outcome measures
Measure	Citalopram n=24 Participants Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.	St. John's Wort n=26 Participants Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.	Placebo n=23 Participants Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment	4.7 Number of events Standard Deviation 4.4	5.0 Number of events Standard Deviation 4.5	3.4 Number of events Standard Deviation 3.0

Adverse Events

Citalopram

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

St. John's Wort

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Mark Hyman Rapaport, M.D.

Cedars Sinai Medical Center

Phone: 310-423-2600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Citalopram n=24 participants at risk Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.	St. John's Wort n=26 participants at risk Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.	Placebo n=23 participants at risk Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
Gastrointestinal disorders Diarrhea	33.3% 8/24 • Number of events 8 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	30.8% 8/26 • Number of events 8 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	4.3% 1/23 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Gastrointestinal disorders Constipation	25.0% 6/24 • Number of events 6 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	30.8% 8/26 • Number of events 8 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	13.0% 3/23 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Gastrointestinal disorders Dry Mouth	25.0% 6/24 • Number of events 6 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	23.1% 6/26 • Number of events 6 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	0.00% 0/23 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Gastrointestinal disorders Nausea/Vomiting	25.0% 6/24 • Number of events 6 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	26.9% 7/26 • Number of events 7 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	17.4% 4/23 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Cardiac disorders Palpitations	12.5% 3/24 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	11.5% 3/26 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	17.4% 4/23 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Cardiac disorders Dizziness on standing	20.8% 5/24 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	15.4% 4/26 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	13.0% 3/23 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Cardiac disorders Chest Pain	4.2% 1/24 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	3.8% 1/26 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	17.4% 4/23 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Skin and subcutaneous tissue disorders Rash	8.3% 2/24 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	7.7% 2/26 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	4.3% 1/23 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Skin and subcutaneous tissue disorders Increased perspiration	16.7% 4/24 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	3.8% 1/26 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	4.3% 1/23 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Skin and subcutaneous tissue disorders Itching	4.2% 1/24 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	7.7% 2/26 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	8.7% 2/23 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Skin and subcutaneous tissue disorders Dry skin	8.3% 2/24 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	11.5% 3/26 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	4.3% 1/23 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Nervous system disorders Headache	41.7% 10/24 • Number of events 10 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	23.1% 6/26 • Number of events 6 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	47.8% 11/23 • Number of events 11 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Nervous system disorders Tremors	16.7% 4/24 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	15.4% 4/26 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	0.00% 0/23 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Nervous system disorders Poor coordination	4.2% 1/24 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	11.5% 3/26 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	4.3% 1/23 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Nervous system disorders Dizziness	12.5% 3/24 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	15.4% 4/26 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	21.7% 5/23 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Eye disorders Blurred vision	20.8% 5/24 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	23.1% 6/26 • Number of events 6 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	17.4% 4/23 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Ear and labyrinth disorders Ringing in ears	12.5% 3/24 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	3.8% 1/26 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	0.00% 0/23 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Renal and urinary disorders Frequent urination	8.3% 2/24 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	11.5% 3/26 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	4.3% 1/23 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Renal and urinary disorders Menstrual irregularity (females)	15.4% 2/13 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	0.00% 0/13 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	27.3% 3/11 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Nervous system disorders Difficulty sleeping	41.7% 10/24 • Number of events 10 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	50.0% 13/26 • Number of events 13 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	30.4% 7/23 • Number of events 7 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Nervous system disorders Sleeping too much	29.2% 7/24 • Number of events 7 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	19.2% 5/26 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	4.3% 1/23 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Reproductive system and breast disorders Loss of sexual desire	29.2% 7/24 • Number of events 7 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	15.4% 4/26 • Number of events 4 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	21.7% 5/23 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Reproductive system and breast disorders Trouble achieving orgasm	33.3% 8/24 • Number of events 8 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	19.2% 5/26 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	21.7% 5/23 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Reproductive system and breast disorders Trouble with erections (male)	45.5% 5/11 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	7.7% 1/13 • Number of events 1 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	16.7% 2/12 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Psychiatric disorders Anxiety	20.8% 5/24 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	19.2% 5/26 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	39.1% 9/23 • Number of events 9 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Psychiatric disorders Poor concentration	25.0% 6/24 • Number of events 6 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	26.9% 7/26 • Number of events 7 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	30.4% 7/23 • Number of events 7 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Psychiatric disorders General malaise	29.2% 7/24 • Number of events 7 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	7.7% 2/26 • Number of events 2 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	21.7% 5/23 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Psychiatric disorders Restlessness	12.5% 3/24 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	30.8% 8/26 • Number of events 8 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	26.1% 6/23 • Number of events 6 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Psychiatric disorders Fatigue	41.7% 10/24 • Number of events 10 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	11.5% 3/26 • Number of events 3 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	21.7% 5/23 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.
Psychiatric disorders Decreased energy	37.5% 9/24 • Number of events 9 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	19.2% 5/26 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.	21.7% 5/23 • Number of events 5 • 12 weeks The Patient-Rated Inventory of Side Effects (PRISE; Rush et al., 2004) was administered at baseline and all subsequent visits. This obtained information not only about the presence or absence of 32 specific adverse events (and the opportunity to write in "others"), but whether those were present at a tolerable or distressing level or constituted a serious adverse event. Vital signs and medication compliance were also assessed at each visit during treatment.