Trial Outcomes & Findings for Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa (NCT NCT01170117)

NCT ID: NCT01170117

Last Updated: 2018-06-29

Results Overview

Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 152 participants
• Primary outcome timeframe: Weekly during 16-week trial and twice during 8 weeks follow-up
• Results posted on: 2018-06-29

Participant Flow

Recruitment took place from December 2010 through June 2016 at each of the five study sites, which are medical clinics: Columbia University-New York State Psychiatric Institute, Weill Cornell Medical College, Centre For Addiction And Mental Health in Toronto, University Of Pittsburgh and Johns Hopkins University.

A total of 25 individuals across sites discontinued the trial prior to group assignment, and 17 were withdrawn by investigators before randomization. These individuals were excluded from the trial due to various reasons such desiring alternate care, and not being interested in medication.

Participant milestones

Measure	Placebo Control group receiving placebo Placebo: Control Group will receive placebo pill.	Olanzapine Group receiving olanzapine Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.
Overall Study STARTED	77	75
Overall Study COMPLETED	47	55
Overall Study NOT COMPLETED	30	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

Baseline characteristics by cohort

Measure	Placebo n=77 Participants Control group receiving placebo Placebo: Control Group will receive placebo pill	Olanzapine n=75 Participants Group receiving olanzapine Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.	Total n=152 Participants Total of all reporting groups
Age, Continuous	30.0 Years STANDARD_DEVIATION 10.9 • n=5 Participants	28.0 Years STANDARD_DEVIATION 10.8 • n=7 Participants	29.0 Years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	71 Participants n=7 Participants	146 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants	67 Participants n=7 Participants	138 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	69 Participants n=7 Participants	140 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	16.69 kg/m2 STANDARD_DEVIATION 1.18 • n=5 Participants	16.79 kg/m2 STANDARD_DEVIATION 1.17 • n=7 Participants	16.7 kg/m2 STANDARD_DEVIATION 1.20 • n=5 Participants

PRIMARY outcome

Timeframe: Weekly during 16-week trial and twice during 8 weeks follow-up

Population: Patients assigned to receive placebo or olanzapine for 16 weeks.

Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo

Outcome measures

Measure	Placebo n=77 Participants Control group receiving placebo Placebo: Control Group will receive placebo pill.	Olanzapine n=75 Participants Group receiving olanzapine Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.
Rate of Weight Change	0.095 kg/m^2 per month Standard Error 0.053	0.260 kg/m^2 per month Standard Error 0.051

PRIMARY outcome

Timeframe: Weekly during 16-week intervention and twice during 8-week follow-up

Comparison of psychological change as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo. The Y-BOCS is divided into two sections: obsessive and compulsive. The scores for each section range from 1 to 20. The overall scores are obtained from adding scores for the two sections, to obtain a range between 2-40. A lower score reflects improvement/ fewer obsessive compulsive symptoms. A score of 25 or more is considered moderately severe, a score of 30 or more is considered severe, and a score of more than 35 is considered very severe.

Outcome measures

Measure	Placebo n=77 Participants Control group receiving placebo Placebo: Control Group will receive placebo pill.	Olanzapine n=75 Participants Group receiving olanzapine Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.
Psychological Change	0.762 YBOCs score units per month Standard Deviation 0.375	0.800 YBOCs score units per month Standard Deviation 0.350

Adverse Events

Placebo

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Olanzapine

Serious events: 16 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=77 participants at risk Control group receiving placebo Placebo: Control Group will receive placebo pill.	Olanzapine n=75 participants at risk Group receiving olanzapine Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.
Psychiatric disorders Patient hospitalized in eating disorder center to pursue higher level of care.	9.1% 7/77 • Number of events 7 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).	14.7% 11/75 • Number of events 11 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).
Injury, poisoning and procedural complications Overdose	0.00% 0/77 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).	2.7% 2/75 • Number of events 2 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).
Cardiac disorders Abnormal EKG	1.3% 1/77 • Number of events 1 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).	1.3% 1/75 • Number of events 1 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).
Injury, poisoning and procedural complications Physical injury	3.9% 3/77 • Number of events 3 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).	2.7% 2/75 • Number of events 2 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant mass	1.3% 1/77 • Number of events 1 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).	0.00% 0/75 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).
Psychiatric disorders Body spasm	1.3% 1/77 • Number of events 1 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).	0.00% 0/75 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).

Other adverse events

Measure	Placebo n=77 participants at risk Control group receiving placebo Placebo: Control Group will receive placebo pill.	Olanzapine n=75 participants at risk Group receiving olanzapine Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.
Musculoskeletal and connective tissue disorders Mild undulating movement in his posterior tongue on the Abnormal Involuntary Movement Scale	0.00% 0/77 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).	1.3% 1/75 • Number of events 1 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).
Skin and subcutaneous tissue disorders Rash	0.00% 0/77 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).	1.3% 1/75 • Number of events 1 • Adverse events were collected during the 24 weeks of study participation (16 weeks of active participation, and 8 weeks of followup).

Additional Information

Dr. Evelyn Attia

Columbia Center for Eating Disorders

Phone: 646-774-8085

Email: ea12@cumc.columbia.edu

Results disclosure agreements

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