Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F1D-BL-HGLA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent adverse events, changes in vital signs, laboratory results and extrapyramidal effects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine Hydrochloride | Drug | |||
| Nizatidine | Drug | |||
| Placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of olanzapine with nizatidine or placebo evaluated by the average alteration between the groups in cognitive control of appetite, disinhibition and susceptibility to hunger, variation of weight and total punctuation in BPRS | ||
| Compare the security of the association of olanzapine with nizatidine and olanzapine and placebo in relation to laboratory values, vital signs, and incidence of extrapyramidal symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Rio de Janeiro |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C492572 | olanzapine-fluoxetine combination |
| D016567 | Nizatidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brazil |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |