Trial Outcomes & Findings for Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia (NCT NCT01032083)

Results Overview

The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview to elicit symptom ratings for 30 symptoms of psychosis, each scored between 1-7. The negative symptoms subscale uses the individual items in the PANSS that Marder identified as negative symptom (blunted affect, emotional withdrawal, poor rapport, passive/ apathetic social withdrawal, motor retardation, active social avoidance and lack of spontaneity/flow of conversation). Scores on these individual items are summed to create the subscale score. The subscale has a range of 7 to 49, with higher scores indicate greater psychopathology

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Citalopram Citalopram: 20mg/day for the first 4 weeks, followed by the option to increase the dose to 40mg per day for the remainder of the study period.	Placebo Placebo: one placebo capsule for the first 4 weeks, followed by the option to increase the dose to two placebo capsules for the remainder of the study period.
Overall Study STARTED	30	32
Overall Study COMPLETED	19	23
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Citalopram n=30 Participants Citalopram: 20mg/day for the first 4 weeks, followed by the option to increase the dose to 40mg per day for the remainder of the study period.	Placebo n=32 Participants Placebo: one placebo capsule for the first 4 weeks, followed by the option to increase the dose to two placebo capsules for the remainder of the study period.	Total n=62 Participants Total of all reporting groups
Age, Continuous	43.02 years STANDARD_DEVIATION 12.3 • n=5 Participants	45.1 years STANDARD_DEVIATION 12.3 • n=7 Participants	44.11 years STANDARD_DEVIATION 12.24 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United Kingdom	30 participants n=5 Participants	32 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview to elicit symptom ratings for 30 symptoms of psychosis, each scored between 1-7. The negative symptoms subscale uses the individual items in the PANSS that Marder identified as negative symptom (blunted affect, emotional withdrawal, poor rapport, passive/ apathetic social withdrawal, motor retardation, active social avoidance and lack of spontaneity/flow of conversation). Scores on these individual items are summed to create the subscale score. The subscale has a range of 7 to 49, with higher scores indicate greater psychopathology

Outcome measures

Outcome measures
Measure	Citalopram n=22 Participants Citalopram: 20mg/day for the first 4 weeks, followed by the option to increase the dose to 40mg per day for the remainder of the study period.	Placebo n=24 Participants Placebo: one placebo capsule for the first 4 weeks, followed by the option to increase the dose to two placebo capsules for the remainder of the study period.
PANSS Negative Symptom Score	21.5 units on a scale Standard Deviation 5	23 units on a scale Standard Deviation 6.2

PRIMARY outcome

Timeframe: 12 weeks

The Heinrichs Quality of Life scale is a 21-item scale based on a semi-structured interview designed to assess deficit symptoms. Each items is scored from 0-6 and the total score is the sum of all item responses. The total score has a range of 0 to 126, with higher scores indicating better functioning.

Outcome measures

Outcome measures
Measure	Citalopram n=21 Participants Citalopram: 20mg/day for the first 4 weeks, followed by the option to increase the dose to 40mg per day for the remainder of the study period.	Placebo n=25 Participants Placebo: one placebo capsule for the first 4 weeks, followed by the option to increase the dose to two placebo capsules for the remainder of the study period.
Heinrich's Quality of Life Scale Score	52 score on a scale Standard Deviation 18.7	49.5 score on a scale Standard Deviation 20

Adverse Events

Citalopram

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Citalopram n=30 participants at risk Citalopram: 20mg/day for the first 4 weeks, followed by the option to increase the dose to 40mg per day for the remainder of the study period.	Placebo n=32 participants at risk Placebo: one placebo capsule for the first 4 weeks, followed by the option to increase the dose to two placebo capsules for the remainder of the study period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.3% 1/30 • Number of events 1 • 3 years	9.4% 3/32 • Number of events 3 • 3 years
Nervous system disorders Headache	3.3% 1/30 • Number of events 20 • 3 years	15.6% 5/32 • Number of events 5 • 3 years
Gastrointestinal disorders Vomitting	6.7% 2/30 • Number of events 2 • 3 years	9.4% 3/32 • Number of events 4 • 3 years
Nervous system disorders Dizziness	16.7% 5/30 • Number of events 5 • 3 years	6.2% 2/32 • Number of events 3 • 3 years

Additional Information

Professor Thomas Barnes

Imperial College London

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place