Trial Outcomes & Findings for D-Cycloserine Enhancement of Exposure in Social Phobia (NCT NCT00633984)

NCT ID: NCT00633984

Last Updated: 2014-05-14

Results Overview

The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations occurring in the last week. Each item is rated from 0-3 for both fear and avoidance with a possible score of 144; 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, and Greater than 95 - Very severe social phobia. Remission was defined as a score of \< 30 on the Liebowitz Social Anxiety Scale

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 169 participants
• Primary outcome timeframe: Week 13
• Results posted on: 2014-05-14

Participant Flow

Participant milestones

Measure	Cognitive Behavioral Group Therapy + 50mg D-Cycloserine Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.	Cognitive Behavioral Group Therapy + 50mg Placebo Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
Overall Study STARTED	87	82
Overall Study COMPLETED	78	69
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Measure	Cognitive Behavioral Group Therapy + 50mg D-Cycloserine Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.	Cognitive Behavioral Group Therapy + 50mg Placebo Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
Overall Study Lost to Follow-up	0	6
Overall Study Withdrawal by Subject	8	7
Overall Study Hospitalized	1	0

Baseline Characteristics

D-Cycloserine Enhancement of Exposure in Social Phobia

Baseline characteristics by cohort

Measure	Cognitive Behavioral Group Therapy + 50mg D-Cycloserine n=87 Participants Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.	Cognitive Behavioral Group Therapy + 50mg Placebo n=82 Participants Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.	Total n=169 Participants Total of all reporting groups
Age, Continuous	34.6 years STANDARD_DEVIATION 10.5 • n=5 Participants	30.5 years STANDARD_DEVIATION 9.8 • n=7 Participants	32.6 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	42 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	40 Participants n=7 Participants	96 Participants n=5 Participants
Region of Enrollment United States	87 participants n=5 Participants	82 participants n=7 Participants	169 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 13

The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations occurring in the last week. Each item is rated from 0-3 for both fear and avoidance with a possible score of 144; 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, and Greater than 95 - Very severe social phobia. Remission was defined as a score of < 30 on the Liebowitz Social Anxiety Scale

Outcome measures

Measure	Cognitive Behavioral Group Therapy + 50mg D-Cycloserine n=87 Participants Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.	Cognitive Behavioral Group Therapy + 50mg Placebo n=82 Participants Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
Liebowitz Social Anxiety Scale (LSAS)	39.19 units on a scale Interval 34.79 to 43.59	42.44 units on a scale Interval 37.94 to 47.03

PRIMARY outcome

Timeframe: Week 13

The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global severity of symptoms. The CGI-I ranges from 1 ("very much improved") to 7 ("very much worse"). Response and remission was defined as an improvement score of 1 ("very much improved") or 2 ("much improved") on the CGI-I.

Outcome measures

Measure	Cognitive Behavioral Group Therapy + 50mg D-Cycloserine n=87 Participants Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.	Cognitive Behavioral Group Therapy + 50mg Placebo n=82 Participants Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
CGI - Clinical Global Impression of Improvement	2.68 units on a scale Interval 2.38 to 2.98	2.95 units on a scale Interval 2.64 to 3.27

Adverse Events

Cognitive Behavioral Therapy + DCS

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Cognitive Behavioral Therapy + Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cognitive Behavioral Therapy + DCS n=87 participants at risk Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.	Cognitive Behavioral Therapy + Placebo n=82 participants at risk Participants received Cognitive Behavioral Group Therapy and Placebo.
General disorders General	8.0% 7/87 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.	4.9% 4/82 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
General disorders Neurological	6.9% 6/87 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.	4.9% 4/82 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
General disorders GI	5.7% 5/87 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.	4.9% 4/82 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
General disorders Cognitive/Emotional	3.4% 3/87 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.	1.2% 1/82 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
General disorders Genitourinary	0.00% 0/87 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.	1.2% 1/82 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
General disorders Other	6.9% 6/87 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.	6.1% 5/82 • Adverse event data were collected for 6 weeks. Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.

Additional Information

Dr. Stefan G. Hofmann

Boston University

Phone: 617 353 9233

Email: shofmann@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place