Trial Outcomes & Findings for DECIFER: Depression and Citalopram In First Episode Recovery (NCT NCT01041274)

Last Updated: 2019-12-17

Results Overview

The Calgary Depression Scale for Schizophrenia (CDSS) is a rater-administered assessment that measures depression in schizophrenia. The scale consists of 9 questions each rated 0 to 3. 0 corresponds with "absent" and 3 corresponds with "severe". The total score for all items is provided for each time point. The minimum score is 0 and the maximum score is 27. A higher score indicates increased depressive symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

95 participants

Primary outcome timeframe

Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Results posted on

2019-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Citalopram Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Overall Study STARTED	49	46
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	23	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DECIFER: Depression and Citalopram In First Episode Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Citalopram n=49 Participants Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo n=46 Participants Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52	Total n=95 Participants Total of all reporting groups
Age, Continuous	23.2 Years STANDARD_DEVIATION 5.09 • n=5 Participants	23.69 Years STANDARD_DEVIATION 4.63 • n=7 Participants	23.44 Years STANDARD_DEVIATION 4.85 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Population: Not all participants completed the CDRS assessment at each time point. Results are reported for all participants who completed the CDRS assessment.

Outcome measures

Outcome measures
Measure	Citalopram n=49 Participants Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo n=46 Participants Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Calgary Depression Scale for Schizophrenia (CDSS) Week 24	1.32 units on a scale Standard Deviation 1.89	1.20 units on a scale Standard Deviation 1.61
Calgary Depression Scale for Schizophrenia (CDSS) Week 40	.96 units on a scale Standard Deviation 1.69	1.21 units on a scale Standard Deviation 1.93
Calgary Depression Scale for Schizophrenia (CDSS) Week 48	.5 units on a scale Standard Deviation .89	1.3 units on a scale Standard Deviation 1.72
Calgary Depression Scale for Schizophrenia (CDSS) Week 52	.4 units on a scale Standard Deviation 1.08	1.15 units on a scale Standard Deviation 1.68
Calgary Depression Scale for Schizophrenia (CDSS) Screening	1.93 units on a scale Standard Deviation 1.74	2.26 units on a scale Standard Deviation 1.74
Calgary Depression Scale for Schizophrenia (CDSS) Baseline	1.83 units on a scale Standard Deviation 1.79	2.58 units on a scale Standard Deviation 2.99
Calgary Depression Scale for Schizophrenia (CDSS) Week 1	2.13 units on a scale Standard Deviation 2.47	1.94 units on a scale Standard Deviation 3.03
Calgary Depression Scale for Schizophrenia (CDSS) Week 2	2.00 units on a scale Standard Deviation 2.34	1.84 units on a scale Standard Deviation 2.53
Calgary Depression Scale for Schizophrenia (CDSS) Week 3	2.4 units on a scale Standard Deviation 2.80	1.87 units on a scale Standard Deviation 2.53
Calgary Depression Scale for Schizophrenia (CDSS) Week 4	1.34 units on a scale Standard Deviation 1.95	1.79 units on a scale Standard Deviation 1.79
Calgary Depression Scale for Schizophrenia (CDSS) Week 5	1.54 units on a scale Standard Deviation 2.11	1.67 units on a scale Standard Deviation 1.78
Calgary Depression Scale for Schizophrenia (CDSS) Week 6	1.29 units on a scale Standard Deviation 1.54	1.07 units on a scale Standard Deviation 1.34
Calgary Depression Scale for Schizophrenia (CDSS) Week 7	1.20 units on a scale Standard Deviation 1.32	2.15 units on a scale Standard Deviation 2.76
Calgary Depression Scale for Schizophrenia (CDSS) Week 8	1.08 units on a scale Standard Deviation 2.27	1.49 units on a scale Standard Deviation 1.82
Calgary Depression Scale for Schizophrenia (CDSS) Week 12	1.41 units on a scale Standard Deviation 2.48	1.32 units on a scale Standard Deviation 2.03
Calgary Depression Scale for Schizophrenia (CDSS) Week 16	.97 units on a scale Standard Deviation 1.44	.72 units on a scale Standard Deviation 1.22
Calgary Depression Scale for Schizophrenia (CDSS) Week 20	1.11 units on a scale Standard Deviation 2.06	1.23 units on a scale Standard Deviation 1.61
Calgary Depression Scale for Schizophrenia (CDSS) Week 28	.67 units on a scale Standard Deviation 1.27	1.14 units on a scale Standard Deviation 1.30
Calgary Depression Scale for Schizophrenia (CDSS) Week 32	.71 units on a scale Standard Deviation 1.12	.81 units on a scale Standard Deviation 1.33
Calgary Depression Scale for Schizophrenia (CDSS) Week 36	.42 units on a scale Standard Deviation .86	1.06 units on a scale Standard Deviation 1.29
Calgary Depression Scale for Schizophrenia (CDSS) Week 44	.63 units on a scale Standard Deviation 1.53	1.55 units on a scale Standard Deviation 1.76

SECONDARY outcome

Timeframe: Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24, 28,32, 36, 40, 44, 48, 52

Population: Not all participants completed the SANS assessment at each time point. Results are reported for all participants who completed the SANS assessment.

The Scale for the Assessment of Negative Symptoms (SANS) is a 25-item rater-administered scale to assess negative symptoms in schizophrenia. Each item is rated from 0 to 5 where 0 is "none" and 5 is "severe". The SANS consists of five subscales: affective flattening/blunting, alogia, avolition/apathy, ahnedonia/asociality, and attention. Each subscale contains a "global rating" item which assesses the overall severity of symptoms within the subscale. The total score consists of a sum of all items except the global ratings and items 10, 23, 24, and 25. The total score is reported for each time point. The minimum total score is 0 and the maximum total score is 85. A higher score indicates increased severity of negative symptoms.

Outcome measures

Outcome measures
Measure	Citalopram n=49 Participants Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo n=46 Participants Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Scale for the Assessment of Negative Symptoms (SANS) Baseline	21.37 units on a scale Standard Deviation 14.25	18.91 units on a scale Standard Deviation 12.08
Scale for the Assessment of Negative Symptoms (SANS) Week 36	8.38 units on a scale Standard Deviation 9.76	11.68 units on a scale Standard Deviation 10.62
Scale for the Assessment of Negative Symptoms (SANS) Screening	19.89 units on a scale Standard Deviation 14.39	16.77 units on a scale Standard Deviation 11.9
Scale for the Assessment of Negative Symptoms (SANS) Week 4	16.98 units on a scale Standard Deviation 14.17	14.58 units on a scale Standard Deviation 10.23
Scale for the Assessment of Negative Symptoms (SANS) Week 8	13.83 units on a scale Standard Deviation 12.04	13.11 units on a scale Standard Deviation 10.58
Scale for the Assessment of Negative Symptoms (SANS) Week 12	12.38 units on a scale Standard Deviation 12.21	14.06 units on a scale Standard Deviation 11.73
Scale for the Assessment of Negative Symptoms (SANS) Week 16	11.08 units on a scale Standard Deviation 11.34	11.48 units on a scale Standard Deviation 10.14
Scale for the Assessment of Negative Symptoms (SANS) Week 20	12.26 units on a scale Standard Deviation 13.10	12.29 units on a scale Standard Deviation 11.78
Scale for the Assessment of Negative Symptoms (SANS) Week 24	12.41 units on a scale Standard Deviation 12.06	13.06 units on a scale Standard Deviation 11.23
Scale for the Assessment of Negative Symptoms (SANS) Week 28	9.9 units on a scale Standard Deviation 11.04	12.59 units on a scale Standard Deviation 11.71
Scale for the Assessment of Negative Symptoms (SANS) Week 32	8.0 units on a scale Standard Deviation 9.15	10.92 units on a scale Standard Deviation 10.77
Scale for the Assessment of Negative Symptoms (SANS) Week 40	9.35 units on a scale Standard Deviation 11.93	10.64 units on a scale Standard Deviation 12.67
Scale for the Assessment of Negative Symptoms (SANS) Week 44	7.54 units on a scale Standard Deviation 8.92	12.64 units on a scale Standard Deviation 12.98
Scale for the Assessment of Negative Symptoms (SANS) Week 48	7.54 units on a scale Standard Deviation 9.10	13.0 units on a scale Standard Deviation 13.88
Scale for the Assessment of Negative Symptoms (SANS) Week 52	13.83 units on a scale Standard Deviation 12.04	11.64 units on a scale Standard Deviation 13.92

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Population: Not all participants completed the BPRS assessment at each time point. Results are reported for all participants who completed the BPRS assessment.

The Brief Psychiatric Rating Scale (BPRS) is a 24-item rater-administered scale assessing overall psychiatric and psychotic symptoms. Items 1-14 are assessed through self-report and items 15-24 are assessed on the basis of observed behavior. Each item is rated from 1 to 7 where 1 is "not present" and 7 is "extremely severe". A score of 0 indicates "not assessed". The total score is a sum of all items and is reported for each time point. The minimum score is 24 and the maximum score is 168, and higher values indicate increased symptom severity.

Outcome measures

Outcome measures
Measure	Citalopram n=49 Participants Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo n=46 Participants Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Brief Psychiatric Rating Scale (BPRS) Week 12	33.8 units on a scale Standard Deviation 10.0	33.2 units on a scale Standard Deviation 7.2
Brief Psychiatric Rating Scale (BPRS) Week 28	29.6 units on a scale Standard Deviation 5.5	31.6 units on a scale Standard Deviation 7.3
Brief Psychiatric Rating Scale (BPRS) Week 44	30.1 units on a scale Standard Deviation 7.9	33.5 units on a scale Standard Deviation 10.1
Brief Psychiatric Rating Scale (BPRS) Week 48	30.0 units on a scale Standard Deviation 6.7	32.6 units on a scale Standard Deviation 9.0
Brief Psychiatric Rating Scale (BPRS) Week 52	29.1 units on a scale Standard Deviation 6.9	32.7 units on a scale Standard Deviation 11.2
Brief Psychiatric Rating Scale (BPRS) Baseline	39 units on a scale Standard Deviation 11.5	38.0 units on a scale Standard Deviation 9.3
Brief Psychiatric Rating Scale (BPRS) Week 4	33.11 units on a scale Standard Deviation 7.3	33.1 units on a scale Standard Deviation 6.7
Brief Psychiatric Rating Scale (BPRS) Week 8	33.3 units on a scale Standard Deviation 9.2	33.2 units on a scale Standard Deviation 8.0
Brief Psychiatric Rating Scale (BPRS) Week 16	27.9 units on a scale Standard Deviation 5.9	29.1 units on a scale Standard Deviation 4.9
Brief Psychiatric Rating Scale (BPRS) Week 20	33.1 units on a scale Standard Deviation 9.9	31.2 units on a scale Standard Deviation 7.5
Brief Psychiatric Rating Scale (BPRS) Week 24	32.6 units on a scale Standard Deviation 9.8	32.7 units on a scale Standard Deviation 7.6
Brief Psychiatric Rating Scale (BPRS) Week 32	29.4 units on a scale Standard Deviation 5.5	29.9 units on a scale Standard Deviation 5.6
Brief Psychiatric Rating Scale (BPRS) Week 36	28.6 units on a scale Standard Deviation 5.3	32.2 units on a scale Standard Deviation 9.7
Brief Psychiatric Rating Scale (BPRS) Week 40	31.1 units on a scale Standard Deviation 7.7	31.4 units on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: Screening, Baseline, Weeks 1-8

Population: Given the low scores on this assessment, data collection was discontinued.

IntraSePT Scale for Suicidal Thinking (ISST) consists of 12 questions rated from 0 to 2 with increasing intensity (i.e. none, weak, moderate to stron). It quantifies the current conscious and overtly expressed suicidal thinking in schizophrenic patients by canvassing various suicidal thoughts and wishes during a 20- to 30-min semi-structured interview. The total score is computed by adding the 12 individual item scores and ranges from 0 to 24. A score of zero indicates low suicidal ideation and a score of 24 indicates high suicidal ideation.

Outcome measures

Outcome measures
Measure	Citalopram n=49 Participants Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo n=46 Participants Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
InterSePT Scale for Suicidal Thinking (ISST) Baseline	0.605 score on a scale Standard Deviation 1.76	0.462 score on a scale Standard Deviation 1.57
InterSePT Scale for Suicidal Thinking (ISST) Week 4	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
InterSePT Scale for Suicidal Thinking (ISST) Week 6	0.125 score on a scale Standard Deviation 0.50	0.0 score on a scale Standard Deviation 0.0
InterSePT Scale for Suicidal Thinking (ISST) Week 7	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
InterSePT Scale for Suicidal Thinking (ISST) Screening	0.184 score on a scale Standard Deviation 0.808	0.643 score on a scale Standard Deviation 2.57
InterSePT Scale for Suicidal Thinking (ISST) Week 1	0.667 score on a scale Standard Deviation 2.14	0.263 score on a scale Standard Deviation 0.806
InterSePT Scale for Suicidal Thinking (ISST) Week 2	0.293 score on a scale Standard Deviation 1.585	0.0 score on a scale Standard Deviation 0.0
InterSePT Scale for Suicidal Thinking (ISST) Week 3	0.136 score on a scale Standard Deviation 0.640	1.00 score on a scale Standard Deviation 3.29
InterSePT Scale for Suicidal Thinking (ISST) Week 5	0.357 score on a scale Standard Deviation 1.34	0.0 score on a scale Standard Deviation 0.0
InterSePT Scale for Suicidal Thinking (ISST) Week 8	0.0 score on a scale Standard Deviation 0.0	0.20 score on a scale Standard Deviation 0.816

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 52

Population: Not all participants completed the QOL assessment at each time point. Results are reported for all participants who completed the QOL assessment.

The Quality of Life Scale (QOL) is a 21-item scale based on a semi-structured interview to assess functional deficits in schizophrenia. Each item is rated on a 7-point scale where 0 indicates a normal level of functioning, or no deficit, and 6 corresponds to more severe deficit. The total score is a sum of all items. The minimum total score is 0 and the maximum total score is 126, higher scores indicate increased impairment in functioning.

Outcome measures

Outcome measures
Measure	Citalopram n=49 Participants Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo n=46 Participants Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Heinrich Quality of Life Scale (QOL) Week 8	86.2 units on a scale Standard Deviation 25.2	87.1 units on a scale Standard Deviation 21.1
Heinrich Quality of Life Scale (QOL) Week 40	100.2 units on a scale Standard Deviation 25.3	91.1 units on a scale Standard Deviation 29.6
Heinrich Quality of Life Scale (QOL) Week 52	86.2 units on a scale Standard Deviation 25.2	95.6 units on a scale Standard Deviation 28.6
Heinrich Quality of Life Scale (QOL) Baseline	71.5 units on a scale Standard Deviation 25.9	75.9 units on a scale Standard Deviation 23.2
Heinrich Quality of Life Scale (QOL) Week 4	81.0 units on a scale Standard Deviation 24.3	83.6 units on a scale Standard Deviation 21.8
Heinrich Quality of Life Scale (QOL) Week 12	86.4 units on a scale Standard Deviation 27.9	90.4 units on a scale Standard Deviation 22.7
Heinrich Quality of Life Scale (QOL) Week 16	89.6 units on a scale Standard Deviation 27.8	92.1 units on a scale Standard Deviation 20.0
Heinrich Quality of Life Scale (QOL) Week 20	86.4 units on a scale Standard Deviation 29.6	91.8 units on a scale Standard Deviation 23.4
Heinrich Quality of Life Scale (QOL) Week 24	87.4 units on a scale Standard Deviation 28.8	92.9 units on a scale Standard Deviation 20.3
Heinrich Quality of Life Scale (QOL) Week 32	98.7 units on a scale Standard Deviation 26.0	98.0 units on a scale Standard Deviation 21.4

Adverse Events

Citalopram

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Citalopram n=49 participants at risk Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo n=46 participants at risk Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Psychiatric disorders Psychiatric Hospitalization	6.1% 3/49 • Number of events 4 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	8.7% 4/46 • Number of events 4 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Incarceration	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Infections and infestations Medical Hospitalization	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Drug-related hospitalization	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.

Other adverse events

Additional Information

Principal Investigator

NYU Langone Medical Center

Phone: 646-754-4843

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Citalopram n=49 participants at risk Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months. Citalopram: 40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.	Placebo n=46 participants at risk Participants will receive a daily dose of placebo for 12 months. Placebo: Placebo by mouth daily for 12 months. Psychoeducation: 16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions Cognitive Behavioral Therapy (CBT): Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI Functional Magnetic Resonance Imaging (fMRI): 3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Infections and infestations Pneumonia	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Akathisia	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Blood and lymphatic system disorders Anemia	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Reproductive system and breast disorders Anorgasmia	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Apathy	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Metabolism and nutrition disorders Appetite decrease	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Metabolism and nutrition disorders Appetite increase	4.1% 2/49 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Eye disorders Blurred vision	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Skin and subcutaneous tissue disorders Cellulitis	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Concentration impaired	4.1% 2/49 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Musculoskeletal and connective tissue disorders Muscle cramp	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Emotional dejection	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Difficulty thinking	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Dizziness upon standing	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 4 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Musculoskeletal and connective tissue disorders Drooling	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Drowsiness	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Drug abuse	2.0% 1/49 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
General disorders Dry mouth	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Faintness	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders False sensation	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Fatigue	2.0% 1/49 • Number of events 3 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Respiratory, thoracic and mediastinal disorders Hiccup	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
General disorders Hit by a motorcycle	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Vascular disorders Hot flashes	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
General disorders Hurt when riding a bike	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Vascular disorders Hypertension	6.1% 3/49 • Number of events 3 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Irritability	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Reproductive system and breast disorders Loss of libido	6.1% 3/49 • Number of events 6 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Memory impaired	4.1% 2/49 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 4 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Mental activity decreased	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Musculoskeletal and connective tissue disorders Muscle twitch	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Gastrointestinal disorders Nausea and vomiting	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	4.3% 2/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Nightmares	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Numbness	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Skin and subcutaneous tissue disorders Rash	4.1% 2/49 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Restlessness	4.1% 2/49 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Reproductive system and breast disorders Amenorrhea	4.1% 2/49 • Number of events 8 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 2 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Sleeplessness	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Metabolism and nutrition disorders Taste alteration	0.00% 0/49 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	2.2% 1/46 • Number of events 4 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Metabolism and nutrition disorders Weight increase	18.4% 9/49 • Number of events 9 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	13.0% 6/46 • Number of events 7 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Psychiatric disorders Sensory hallucinations	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Nervous system disorders Sleep disturbed	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
Vascular disorders Tachycardia	10.2% 5/49 • Number of events 10 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.
General disorders Teeth grating	2.0% 1/49 • Number of events 1 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.	0.00% 0/46 Non-serious adverse events were reported through the Systematic Assessment of Treatment Emergent Effects (SAFTEE) questionnaire unless otherwise specified.